Changes to the Regulatory Landscape, and what they mean.

Top Stories

FDA Approves Fall 2026 COVID Shots, Keeps Narrow Use

FDA approved updated, XFG-adapted 2026–2027 formula COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Novavax on 27–28 August, each cleared by a strain-change supplement rather than a new licensing review. All three keep the same restricted indication FDA adopted a year ago: adults 65 and older, plus younger people with a qualifying high-risk condition — not the general population.

By Connor Griggs30 August 20265 min read

Devices

MHRA Flags Wear Risk in Five Modular-Neck Hip Implants

Device Safety Information notice DSI/2026/010, published 26 August, found increased wear and corrosion at the modular junctions of cobalt-chrome dual-taper hip systems sold in the UK from 2007 to 2019 by five manufacturers. MHRA estimates about 750 patients still carry one, and is directing NHS trusts to identify and clinically review every one of them.

30 August 20265 min read

FDA

FDA Warns Alar Over Ads for Its Unapproved Ketamine Drug

FDA's Office of Prescription Drug Promotion sent Alar Pharmaceuticals an untitled letter, dated 28 August, over an exhibit booth display and brochure it showed at the American Psychiatric Association's May conference — promotional materials for ALA-3000, a ketamine-based drug for treatment-resistant depression that has not been approved for any use.

30 August 20264 min read

FDA

FDA Authorizes New JUUL2 E-Cigarette System

FDA issued marketing granted orders for Juul Labs’ next-generation JUUL2 device on 28 August — the company’s first new hardware in roughly a decade — concluding that adult-smoker switching data outweighed youth-appeal risk even for a menthol-flavored pod.

28 August 20265 min read

Clinical

FDA Approves First Drug for Polycythemia Vera

FDA approved Takeda’s Mimrylo (rusfertide) on 28 August, the first drug of its kind for polycythemia vera — a hepcidin-mimetic peptide that starved the blood disorder’s excess red-cell production in a Phase 3 trial, cutting most patients’ need for routine phlebotomy.

28 August 20264 min read

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Showing 84 of 84 stories

Two scientists in lab coats and safety goggles examine a test tube of colored liquid in front of a chalkboard covered in chemistry equations FDA 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 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 FDA 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 FDA 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 Clinical 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 Clinical 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 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 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 FDA 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 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 FDA 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 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 Clinical 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 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 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 FDA 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 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 Devices 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 Clinical 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 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 FDA 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 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 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 Clinical 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 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 FDA 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 Clinical 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 Devices 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 FDA 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 Manufacturing 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 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 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 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 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 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 Manufacturing 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 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 Clinical 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 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 FDA 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 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 Clinical 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 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 FDA 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 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 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 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 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 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 FDA 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 FDA 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 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 FDA 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 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 Clinical 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 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 FDA 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 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 FDA 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 FDA 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 FDA 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 FDA 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 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 Guidance 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 Devices 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 Devices 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 FDA 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 Clinical 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 FDA 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 Clinical 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 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 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 Manufacturing 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 EU MDR & IVDR 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 FDA 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 FDA 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 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 Devices 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 FDA 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 FDA 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 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 FDA 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 EU MDR & IVDR EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story

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