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Biologics

Vaccines, antibodies, biosimilars, blood and plasma products: licences, label changes, safety reviews and the guidance behind them.

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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

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

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 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 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 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 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

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 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

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