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Drugs & Biologics

Approvals, complete response letters, advisory committees, labelling and safety reviews for drugs, vaccines, and cell and gene therapies.

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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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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