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A researcher in a lab coat examines petri dish cultures under a microscope Drugs & Biologics CHMP Clears First mAb Biosimilar Under New EU Path Sep 22, 20266 min read Read the story A neoclassical government building's columns and pediment against a blue sky Guidance & Policy FDA Swaps 'Animal Testing' for 'Nonclinical' in Rules Sep 22, 20265 min read Read the story A man in a suit reviews a document closely with a magnifying glass Devices & Diagnostics MHRA Curbs Wireless Fetal Monitor Signal Mix-Ups Sep 22, 20265 min read Read the story A researcher in a lab coat examines a sample closely, in profile, under laboratory lighting Spotlight Koning Health Wins TGA Approval for Breast CT System Sep 21, 20266 min read Read the story A businessperson in a blazer stands for a team portrait in a modern office setting Spotlight SK Biopharmaceuticals Completes Japan Epilepsy Approval Sep 21, 20266 min read Read the story Two researchers in a laboratory examine a blue-tinted flask together Spotlight Circle Pharma Raises $92.5M Series E for Cancer Drug Sep 21, 20266 min read Read the story A laboratory scientist in blue nitrile gloves uses a pipette over a rack of test tubes Drugs & Biologics FDA Grants Fast Track to PureTech's MDS Antibody Sep 21, 20265 min read Read the story A researcher in safety glasses and blue gloves inspects a laboratory sample Drugs & Biologics CHMP Backs Corcept's Lifyorli for Ovarian Cancer Sep 21, 20266 min read Read the story Three executives in business suits clasp hands together in a celebratory gesture Spotlight Sling Nets $123M to Push Eye Drug Into Phase 3 Sep 20, 20266 min read Read the story A researcher in a lab coat and glasses examines a flask of purple liquid held up to the light Spotlight Cyllene Wins FDA RMAT Status for Bladder Gene Therapy Sep 20, 20266 min read Read the story Two officials in dark suits sign documents at a conference table with a European Union flag between them Drugs & Biologics CHMP Backs AstraZeneca's Klygefa for Rare Disorder Sep 20, 20265 min read Read the story A scientist in a white lab coat, blue gloves and safety glasses looks through a microscope in a laboratory Drugs & Biologics FDA Approves Lilly's Inluriyo-Verzenio Combo Sep 20, 20266 min read Read the story A professional in a dark blazer reviews a colorful bar and pie chart report at a desk in a bright office Guidance & Policy FDA Drafts an eSTAR Template for Device PMAs Sep 20, 20265 min read Read the story A woman in a pinstripe blazer at a table with notes and a microphone during a press briefing Spotlight RegCell Raises $66M for Nobel-Backed Treg Therapy Sep 19, 20266 min read Read the story An older man in glasses answers questions as microphones and a phone are held toward him Spotlight Shoulder Innovations Clears FDA Hurdle for N-22 Implant Sep 19, 20265 min read Read the story A man at a desk with two monitors annotates a printed document with a pen Spotlight FemPulse Earns CE Mark for Wearable Bladder Ring Sep 19, 20266 min read Read the story A team of colleagues in a bright office celebrate a milestone, tossing papers into the air around a conference table Drugs & Biologics FDA Approves First Drug for Ataxia in Rare A-T Sep 19, 20265 min read Read the story A close-up of a hand in a pinstripe suit signing a regulatory document on a clipboard Devices & Diagnostics FDA Clears Neptune Medical's Robotic Endoscope Sep 19, 20265 min read Read the story Two officials sign documents at a table bearing European Union and American flags while colleagues review papers standing behind them Drugs & Biologics CHMP Recommends Novo's Frehemgo for Haemophilia A Sep 19, 20265 min read Read the story A close-up of a hand signing a contract document with a gold pen next to a laptop Spotlight Matisse Raises €14M for Phase 2 Sepsis Drug Trial Sep 18, 20265 min read Read the story Three people in business attire speak into microphones held out by reporters in a conference room Spotlight CorTec Lands Second FDA Breakthrough Nod for BCI Sep 18, 20266 min read Read the story A researcher in a lab coat gestures toward a whiteboard of chemical formulas while a colleague examines a sample under a microscope Spotlight Scholar Rock Wins FDA Nod for First SMA Muscle Drug Sep 18, 20266 min read Read the story A researcher wearing safety glasses and a white lab coat looks through a microscope eyepiece while adjusting a sample slide Drugs & Biologics FDA Approves First Gene Therapy for Sanfilippo Type A Sep 18, 20265 min read Read the story A woman leans over a desk signing an official document while a colleague looks on in a bright office Guidance & Policy FDA Denies Bid to Exempt Radiology AI From 510(k) Sep 18, 20265 min read Read the story A senior scientist in a protective coverall speaks with a colleague in a lab beside a whiteboard covered in chemical notation Drugs & Biologics FDA Updates IBTROZI Label With 4-Year Response Data Sep 18, 20264 min read Read the story A researcher in a lab coat adjusts a microscope while a colleague in scrubs assists, examining a sample under magnification Drugs & Biologics FDA Clears First Skin-Cancer Photodynamic Therapy Sep 17, 20264 min read Read the story Colleagues seated at a conference table with microphones review documents during a panel discussion Devices & Diagnostics FDA Clears First Robotic LigaSure Vessel Sealer Sep 17, 20264 min read Read the story A doctor in a white coat and a nurse in blue scrubs review a patient's file together in a clinic corridor Devices & Diagnostics MHRA Alert: Hoist Falls Have Killed Two a Year Sep 17, 20264 min read Read the story Pharming Group's glass-fronted global headquarters in Leiden, the Netherlands Spotlight Pharming Wins FDA Nod to Extend Joenja to Kids Sep 17, 20265 min read Read the story A paramedic in blue gloves holds an LVOne test cassette in front of a yellow NHS ambulance Spotlight UpFront Diagnostics Earns CE Mark for Stroke Test Sep 17, 20265 min read Read the story Illustration of the Emboliner embolic protection filter deployed across the aortic arch during TAVR Spotlight Emboline Clears FDA Hurdle for TAVR Debris Filter Sep 17, 20266 min read Read the story Two lab scientists in white coats test glassware samples on a bright laboratory bench Drugs & Biologics TGA: Counterfeit Retatrutide Hid 8x-Dose Semaglutide Sep 16, 20265 min read Read the story An office worker stamps an official document at a desk Devices & Diagnostics FDA Breakthrough Status for Remote Robotic Stroke Device Sep 16, 20266 min read Read the story An executive in a navy suit signs an official document at a wooden desk Drugs & Biologics Cogent's Bezuclastinib Notches Third Simultaneous NDA Sep 16, 20265 min read Read the story A young woman wearing an iLet Bionic Pancreas pump clipped at her waist Spotlight Beta Bionics Wins FDA Clearance for Mint Patch Pump Sep 15, 20265 min read Read the story Rendering of bacteriophages landing on the rippled blue surface of a bacterial cell Spotlight Armata Wins Breakthrough Status for Phage Therapy AP-SA02 Sep 15, 20265 min read Read the story Diagram of the JBS-003 approach with F-MISO PET scans of an oropharyngeal tumor Spotlight Juniper Lands Breakthrough Status for Hypoxia PET Tracer Sep 15, 20265 min read Read the story Two officials review a document handed across a desk in a government office, a U.S. flag in the background Guidance & Policy FDA Hears Fight Over Who Can Give Psychedelic Therapy Sep 15, 20265 min read Read the story A gloved hand records readings on a clinical trial data sheet on a clipboard Drugs & Biologics RASONQUE Wins Breakthrough Status for First-Line Use Sep 15, 20264 min read Read the story A scientist examines colorful test tubes and vials under a microscope in a laboratory Drugs & Biologics FDA Approves Telix's Pixclara for Glioma Imaging Sep 14, 20264 min read Read the story Two lab technicians in a clinical laboratory review blood sample vials and analyzer readouts Devices & Diagnostics FDA Grants Nutromics' Patch Breakthrough Status Sep 11, 20264 min read Read the story An executive reviews documents from a red folder while standing near a window Devices & Diagnostics FDA Clarifies Path for Spectral's Sepsis Device Sep 11, 20264 min read Read the story The dome of the U.S. Capitol building with an American flag flying in front against a blue sky Guidance & Policy FDA's CDRH Launches Rare Disease Device Initiative Sep 13, 20265 min read Read the story A woman in a red blazer reviews and signs printed documents at a white desk Drugs & Biologics France Warns 1.6 Million Women on Pill Meningioma Risk Sep 13, 20265 min read Read the story A scientist in a white lab coat and blue nitrile gloves stands at a laboratory bench beside petri dishes and glass flasks Manufacturing & Quality Teva Canada Recalls Acetaminophen Over Resin Risk Sep 13, 20264 min read Read the story A man in a navy suit sits at a wood desk reviewing a printed document, with a U.S. flag and bookshelf of framed certificates behind him Guidance & Policy FDA Names Permanent CDER, CBER Chiefs, New AI Post Sep 12, 20265 min read Read the story A close-up of a hand signing an official multi-page form on a desk, with reading glasses resting nearby Guidance & Policy EMA Extends PV Inspections to Cover Subcontractors Sep 12, 20264 min read Read the story Two professional women in coats stand on courthouse steps discussing a document held in a black folder Guidance & Policy MHRA Panel Proposes 'L-Plates' for AI in Healthcare Sep 12, 20264 min read Read the story A scientist in a white lab coat and blue nitrile gloves uses a pipette to examine a sample in a small vial Drugs & Biologics FDA Clears Hyrnuo for First-Line HER2-Mutant Lung Cancer Sep 11, 20265 min read Read the story A scientist in a lab coat carefully pours liquid from a flask into a beaker for measurement Guidance & Policy FDA Eases Compounding Rules for Newborn IV Nutrition Sep 11, 20265 min read Read the story A close-up of a hand signing an official document with a pen Drugs & Biologics EMA Reviews Injectable Iron Drugs Over Bone-Risk Reports Sep 11, 20264 min read Read the story Two scientists in lab coats and safety goggles examine a test tube of colored liquid in front of a chalkboard covered in chemistry equations Drugs & Biologics FDA Approves Fall 2026 COVID Shots, Keeps Narrow Use Aug 30, 20265 min read Read the story Two masked researchers in white lab coats confer over a clipboard in a laboratory, standing beside a microscope and glassware Devices & Diagnostics MHRA Flags Wear Risk in Five Modular-Neck Hip Implants Aug 30, 20265 min read Read the story Two researchers in cleanroom hairnets and gowns talk beside a whiteboard covered in chemistry notation Drugs & Biologics FDA Warns Alar Over Ads for Its Unapproved Ketamine Drug Aug 30, 20264 min read Read the story The Utah State Capitol building under a clear blue sky, with American flags flying in front Guidance & Policy FDA Authorizes New JUUL2 E-Cigarette System Aug 28, 20265 min read Read the story A researcher examines a specimen through a microscope while a colleague takes notes on a tablet in a bright laboratory Drugs & Biologics FDA Approves First Drug for Polycythemia Vera Aug 28, 20264 min read Read the story Two researchers in lab coats and safety glasses examining a specimen through a microscope Drugs & Biologics FDA Approves First Oral Drug for Dermatomyositis Aug 27, 20265 min read Read the story Two gowned staff walking and reviewing notes together in a bright cleanroom corridor Devices & Diagnostics FDA Clears Spineart's Robotic Spine Screw App Aug 26, 20264 min read Read the story Two officials in business suits at a conference table with a U.S. flag, one signing a document Manufacturing & Quality Boston Scientific Cyberattack Halts Device Shipments Aug 26, 20265 min read Read the story The dome of the California State Capitol building against a deep blue sky, with a tree visible at the frame's edge Drugs & Biologics FDA Approves Rasonque, First RAS-Targeted Cancer Drug Aug 26, 20265 min read Read the story The Texas State Capitol dome against a clear blue sky, with the American and Texas flags flying from an adjacent rooftop Devices & Diagnostics FDA Clears Abbott's Libre Duo Glucose-Ketone Monitor Aug 25, 20265 min read Read the story Two masked researchers in a lab examine a beaker of green solution and adjust a microscope and test tubes on a workbench Drugs & Biologics FDA Approves Ziihera Regimens for Gastric Cancer Aug 25, 20265 min read Read the story The illuminated dome of the Utah State Capitol building at twilight against a soft pink sky Devices & Diagnostics FDA Clears Masimo's Root With LiDCO for Oxygen Delivery Aug 25, 20264 min read Read the story Three scientists in a sunlit lab examine a bottle and a bowl of solution while adjusting laboratory equipment Drugs & Biologics EU Approves GSK's Twice-Yearly Asthma Drug Exdensur Aug 25, 20265 min read Read the story The gold dome of the Georgia State Capitol building rises against a partly cloudy blue sky Devices & Diagnostics FDA Clears Tempus's AI Tool for Pulmonary Hypertension Aug 25, 20264 min read Read the story A man in a suit signs paperwork at a desk while a colleague reviews a document beside him in a wood-paneled office with an American flag Guidance & Policy FDA Issues 55 New Bioequivalence Guidances for Generics Aug 25, 20265 min read Read the story Two masked lab researchers review notes on a clipboard while operating a microscope, surrounded by lab glassware Drugs & Biologics FDA Extends Review of Capricor's Duchenne Therapy Aug 24, 20265 min read Read the story The dome of the United States Capitol against a clear blue sky, with a jet aircraft passing high to its right Devices & Diagnostics FDA Classifies Enroute Carotid Recall as Class I Aug 24, 20265 min read Read the story Two colleagues in surgical caps and protective gowns review notes on a tablet in a bright laboratory office Guidance & Policy FDA Recognizes 14 Updated Medical Device Standards Aug 24, 20265 min read Read the story A researcher in white scrubs examines a conical flask of blue solution while a colleague takes notes across the bench Drugs & Biologics EU Clears Tecvayli Plus Daratumumab for Myeloma Aug 24, 20265 min read Read the story Two colleagues review a signed legal document together at a glass table, one holding a pen to the page Guidance & Policy FDA Finalizes Guidance on Generic Drug TE Codes Aug 23, 20266 min read Read the story A senior scientist in a cleanroom gown and hairnet adjusts a microscope while a gowned colleague assists at the bench Guidance & Policy FDA Finalizes FAQ Guide for Cell, Gene Therapies Aug 23, 20266 min read Read the story A person in a red blazer signs a paper form on a desk, pen in hand Devices & Diagnostics MHRA Warns Against Infant Gas-Relief Catheters Aug 23, 20265 min read Read the story A man in a suit reviews and signs a paper document at a desk, with an American flag in the background Guidance & Policy FDA Revises Guidance on ANDA vs. 505(b)(2) Filings Aug 20, 20265 min read Read the story The U.S. Supreme Court Building in Washington, D.C., framed by blooming cherry trees under a clear blue sky Drugs & Biologics FDA Approves First Gene Therapy for GSDIa Aug 20, 20266 min read Read the story Two lab specialists in white coats and safety glasses examine a blood-collection tube in a clinical laboratory Devices & Diagnostics FDA Authorizes First Robotic Blood-Draw Device Aug 20, 20266 min read Read the story Two masked lab scientists in white coats and safety goggles examine test tubes beside a microscope Guidance & Policy FDA Eases Path for Cancer Companion Diagnostics Aug 19, 20265 min read Read the story A man in a dark suit closely reads a folded paper document Guidance & Policy MHRA Clarifies UK Path for Microbiome Medicines Aug 19, 20265 min read Read the story The US Supreme Court building with cherry blossoms and an American flag under a clear blue sky Guidance & Policy FDA Weighs a Competency Test for AI Medical Devices Aug 19, 20265 min read Read the story Two researchers in white lab coats and safety goggles review data on a clipboard beside a microscope in a bright laboratory Drugs & Biologics FDA Clears LEROCHOL Autoinjector, Adds CV Risk Claim Aug 18, 20265 min read Read the story The US Capitol building with its dome and colonnade under a bright blue sky Guidance & Policy FDA's GDUFA IV Plan Would Raise Foreign Drug Fees Aug 18, 20265 min read Read the story Two lab technicians in cleanroom garb examining a sample under a microscope in a bright diagnostics laboratory Devices & Diagnostics FDA Sets a September Panel on GRAIL's Galleri Blood Test Aug 17, 20266 min read Read the story Two gowned technicians in hairnets and masks conferring over a microscope and lab notes in a cleanroom Manufacturing & Quality FDA Flags Novo Nordisk's Indiana Plant as Highest Risk Aug 17, 20266 min read Read the story A close-up of a man in a suit signing a printed document with a pen at a wooden desk Guidance & Policy MHRA to Require Briefing Documents for Scientific Advice Aug 17, 20265 min read Read the story A stone government building with a domed clock tower and a large American flag flying from a pole out front, under a bright blue sky Guidance & Policy FDA Sets September Meeting on PDUFA VIII Fee Deal Aug 16, 20265 min read Read the story Two gowned, hairnet-capped laboratory researchers examining a sample under a microscope, one adjusting her glasses to look into the eyepiece Devices & Diagnostics FDA Grants Breakthrough Status to Freenome Lung Test Aug 16, 20265 min read Read the story Two men in suits seated with an American flag behind them, one writing on a document held on a clipboard while the other reviews papers Drugs & Biologics FDA Grants Hearing on Generic Concerta After Decade Aug 16, 20265 min read Read the story A government building dome with classical columns rises above a city skyline at sunset Guidance & Policy FDA Drafts New Guidance on Drug Container Closures Aug 15, 20265 min read Read the story Two gowned, masked laboratory researchers in hairnets examining a sample under a microscope while taking notes Drugs & Biologics MHRA Approves Vimseltinib for Giant Cell Tumours Aug 15, 20264 min read Read the story A gold-domed capitol building with an American flag rises above green trees against a partly cloudy sky Guidance & Policy FDA Widens Type D Meetings, Narrows INTERACT Use Aug 14, 20265 min read Read the story A researcher in a lab coat and hairnet looks into a microscope at a bench lined with glassware, with a colleague working at a computer behind her Drugs & Biologics FDA Approves Bristol Myers' First CELMoD for Myeloma Aug 14, 20264 min read Read the story A close-up of a white neoclassical building's pediment and arched colonnade against a pale sky Devices & Diagnostics TGA Suspends Supply of Corpuls Defibrillators Aug 14, 20265 min read Read the story A smiling professional in glasses and a tweed blazer reads a printed document by a sunlit skylight window Drugs & Biologics UK First in Europe to Approve Lilly's Foundayo Pill Aug 13, 20265 min read Read the story Two masked lab researchers in white coats and safety glasses review notes on a clipboard beside a microscope Manufacturing & Quality FDA Posts First Two Warning Letters Under New QMSR Aug 13, 20266 min read Read the story A woman in an office reviews a paper case folder beside a tall stack of aged file records and a laptop Clinical Trials FDA Warns Investigator Over Trial Drug Accountability Aug 13, 20265 min read Read the story Two masked, gowned laboratory researchers in a cleanroom review a sample slide loaded on a light microscope Devices & Diagnostics FDA Lets Proscia Add Scanners Without New 510(k)s Aug 6, 20265 min read Read the story A low sun lights the dome and pediment of a neoclassical government capitol building against a deep blue sky Devices & Diagnostics MHRA Lifts Suspension on Belzer Organ-Preservation Fluid Aug 6, 20264 min read Read the story A masked clinician in scrubs examines a handheld stamping device over paperwork on an exam-room counter Devices & Diagnostics FDA Clears Sight Sciences' OMNI Ultra for Glaucoma Aug 4, 20265 min read Read the story A row of Corinthian columns and classical stone statuary lines the curved facade of a government building Devices & Diagnostics MHRA Flags Ventilator Failure Risk in Dräger Atlan Units Aug 4, 20265 min read Read the story The dome of the U.S. Capitol rises against a partly cloudy blue sky, framed by trees on the west lawn Manufacturing & Quality FDA Launches Council to Overhaul Its Inspections Aug 3, 20266 min read Read the story A scientist in a white lab coat and safety glasses reviews handwritten notes on a clipboard in a laboratory corridor, with a colleague behind her Drugs & Biologics FDA Approves Replimune's Twice-Rejected Melanoma Drug Aug 6, 20266 min read Read the story A researcher in a white lab coat and blue nitrile gloves handles laboratory titration equipment while wearing safety glasses Drugs & Biologics FDA Approves Takeda's Orzeyful for Narcolepsy Type 1 Aug 5, 20264 min read Read the story A judge in black robes signs a document at a wooden desk beside a statue of Lady Justice and a gavel Clinical Trials MHRA Plans a 14-Day First Review for Phase 1 Trials Aug 4, 20265 min read Read the story The dome of the U.S. Capitol rises against a clear blue sky, an American flag flying from its balustrade Drugs & Biologics FDA Approves First mRNA Flu Vaccine, Moderna's mFLUSIVA Aug 5, 20266 min read Read the story Two researchers in cleanroom coveralls, hairnets and masks review data on a computer monitor in a lab Devices & Diagnostics FDA Clears BlueWind's Revi Extend Bladder Implant Aug 5, 20265 min read Read the story A gloved researcher holds a pipette over a sample tube while a colleague looks on in a laboratory Drugs & Biologics MHRA's ILAP Passports Go to Liver Cancer, Dementia Drugs Aug 4, 20265 min read Read the story A gloved researcher adjusts the lens turret of a laboratory microscope during a bench inspection Devices & Diagnostics FDA Classifies Ventilator, Heart-Pump Recalls as Class I Aug 3, 20265 min read Read the story A row of Corinthian columns rises along the stone facade of a government office building flying American flags Guidance & Policy FDA Reopens Comment Period on Title 21 Terminology Rule Aug 3, 20264 min read Read the story Four small glass vials with red and blue caps scattered across a blue background Guidance & Policy FDA Drafts Rules for Biosimilar Autoinjectors, Syringes Aug 3, 20265 min read Read the story A researcher in a hairnet and lab coat looks through a benchtop microscope while adjusting its focus knob Clinical Trials FDA Debars Research Site Owners Who Faked Trial Data Aug 3, 20265 min read Read the story A person signs a printed document by hand with a pen while a colleague stands nearby at a wooden table Drugs & Biologics FDA Grants Breakthrough Status to Lilly's KRAS Drug Aug 3, 20264 min read Read the story Two researchers in a laboratory, one examining a sample under a microscope while a colleague works at a fume hood in the background Drugs & Biologics FDA Panel Votes 9-3 Against Capricor's DMD Heart Drug Aug 2, 20266 min read Read the story A gloved hand lifts a glass vial from a row of vials on a laboratory bench, its label left blank Drugs & Biologics FDA Licenses the First Freeze-Dried Plasma for the US Aug 2, 20265 min read Read the story An assortment of pharmaceutical blister packs holding pills and capsules of varying colors spread across a white surface Guidance & Policy FDA Finalizes Adhesion Rules for Generic Skin Patches Aug 2, 20265 min read Read the story A loose pile of white, oblong pharmaceutical tablets spread across a light blue background Clinical Trials FDA Finalizes Three Cancer Trial Eligibility Guidances Jul 30, 20265 min read Read the story Loose orange, pink, and yellow tablets scattered across a light gray surface, softly out of focus Guidance & Policy MHRA Draws the Line on AI Scribes as Medical Devices Jul 29, 20265 min read Read the story A gloved hand lifts a rack of purple-capped sample collection tubes at a testing table, with a rapid-test box in the background Guidance & Policy FDA Gives Home COVID Tests a Permanent Class II Address Jul 27, 20265 min read Read the story Two colleagues review a printed self-injection instruction sheet next to an open laptop Drugs & Biologics FDA Approves MannKind's 10-Second Heart-Failure Autoinjector Jul 27, 20265 min read Read the story A gloved hand adjusts the focus stage of a laboratory microscope holding a slide Drugs & Biologics CHMP Rejects Arimoclomol Again; Zevra Seeks Re-Examination Jul 27, 20266 min read Read the story A researcher wearing glasses looks through a binocular microscope while a colleague in a lab coat stands in the background Drugs & Biologics FDA's Cell Therapy Panel Revisits a Once-Rejected DMD Drug Jul 26, 20266 min read Read the story A gloved hand reaches for a rack of blood sample tubes with pink caps on a laboratory bench Drugs & Biologics CHMP Backs the EU's First Refillable Eye Implant Jul 26, 20266 min read Read the story Blister packs holding rows of blue, yellow, white, and pink tablets, viewed close up on a wooden table Manufacturing & Quality FDA Publishes Its Playbook for Fast-Track CMC Readiness Jul 26, 20265 min read Read the story A person in a dark jacket signs printed documents at a wooden desk while colleagues stand nearby Sponsored Inside the Free 510(k) Course Built From the Primary Record Jul 26, 20264 min read Read the story Three men in business suits stand at a lectern with a U.S. flag behind them, one gesturing as he speaks Devices & Diagnostics FDA Picks Dexcom as First TEMPO Pilot Participant Jul 24, 20266 min read Read the story A woman in a lilac blazer speaks into a microphone while reading from a paper at a wooden lectern Drugs & Biologics MHRA Approves the World's First Low-Carbon Asthma Inhaler Jul 24, 20265 min read Read the story A woman in glasses smiles while speaking at a lectern beside a European Union flag, addressing seated attendees Guidance & Policy Brussels Says Only Manufacturers May Assign a Device's UDI Jul 24, 20265 min read Read the story A scientist at FDA's Center for Biologics Evaluation and Research examining a cell-culture flask under an inverted microscope Drugs & Biologics FDA Sets a July 30 Panel on Replimune's Melanoma Drug Jul 17, 20265 min read Read the story Buildings 1 and 21 at the entrance to the FDA's White Oak campus, with the Maryland and agency flags flying Guidance & Policy FDA Can Now Ask the Public for OTC Monograph Data Jul 17, 20265 min read Read the story Gloved hands loading sample tubes into a benchtop centrifuge in an FDA laboratory Guidance & Policy FDA Retires a 1995 Guidance on Topical Steroids Jul 17, 20265 min read Read the story FDA Building 66, home of the Center for Devices and Radiological Health Guidance & Policy MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock Jul 16, 20266 min read Read the story Rows of empty seats facing an FDA-branded screen in the White Oak Great Room Drugs & Biologics FDA Sets a September Hearing on Psychedelic Therapy Jul 16, 20265 min read Read the story A scientist working at a cabinet in an FDA laboratory Manufacturing & Quality FDA Would Let Distributed Manufacturers Register Once Jul 16, 20266 min read Read the story A gloved hand holding a tablet over dissolution-testing equipment in an FDA laboratory Guidance & Policy FDA's OTC Monograph Meetings Guidance Is Final Jul 16, 20265 min read Read the story The Food and Drug Administration sign above the entrance to the agency's headquarters Clinical Trials FDA's Psychedelics Guidance Is Final, After Three Years Jul 15, 20265 min read Read the story The hemicycle of the European Parliament in Brussels Guidance & Policy EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story