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Biologics

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

60 stories

Regulatory News has published 60 Biologics stories between 26 July 2026 and 1 November 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 1 November 2026.

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A professional in business attire standing outside an office building, a generic stand-in for a regulatory affairs professional Drugs & Biologics EMA Opens Safety Review of Immunoglobulin Batches Nov 1, 20266 min read Read the story Bambusa Therapeutics' three-dimensional rendering of a bispecific antibody, in green, white and blue, on a deep navy background Spotlight Bambusa Therapeutics Prices $168.9M Nasdaq IPO Oct 31, 20268 min read Read the story A clinician uses a handheld ultrasound probe to examine a patient's shoulder joint in a clinic, a generic stand-in for rheumatologic assessment Drugs & Biologics FDA Approves Ilumya for Psoriatic Arthritis Oct 31, 20265 min read Read the story Xbrane Biopharma colleagues around a conference table with laptops in a meeting room Spotlight Xbrane Wins FDA Nod for Lucamzi Eye Biosimilar Oct 29, 20267 min read Read the story Three researchers in white lab coats examining samples on a bright lab bench, a generic stand-in for ADC research Spotlight Medicovestor Earns FDA Fast Track for Pancreatic ADC Oct 29, 20266 min read Read the story A smiling executive in a dark suit on an office terrace, a generic stand-in for Novo Nordisk leadership Drugs & Biologics FDA Approves Weekly Insulin Awiqli for Pediatric T2D Oct 27, 20265 min read Read the story Three physicians in white coats review a patient's chart and medication together at a desk For Physicians FDA Approves Hibsago, First Antisense Hepatitis B Drug Oct 26, 20269 min read Read the story A confident executive in a bright office, a generic stand-in for AstraZeneca/Alexion leadership For Physicians Ultomiris Cleared for IgAN; Kidney Benefit Still Unproven Oct 25, 202612 min read Read the story A clinician administers an injection into a patient's arm during a home visit, a generic stand-in for vaccine administration Spotlight Nuravax Wins FDA Fast Track for Alzheimer's Vaccine Oct 25, 20267 min read Read the story A confident executive holding a clipboard in a bright, minimal office, a generic stand-in for AstraZeneca leadership Drugs & Biologics FDA Clears First C5 Inhibitor for IgA Kidney Disease Oct 25, 20266 min read Read the story The Austrian Parliament building in Vienna behind the Athena fountain under a clear blue sky, a generic European-institutional stand-in Drugs & Biologics CHMP Rejects Omeros' Narsoplimab for Second Time Oct 25, 20266 min read Read the story A senior executive in a dark blouse standing by wood shelving, a generic stand-in for AbbVie leadership For Physicians FDA Approves Subcutaneous-Only Skyrizi Induction Oct 24, 20268 min read Read the story The Samsung Bioepis headquarters in Songdo, Incheon, a white office block with a glass tower bearing the company name Spotlight Samsung Bioepis Earns FDA Fast Track for First ADC Oct 24, 20267 min read Read the story A smiling executive in a bright office lobby, a generic stand-in for AbbVie leadership announcing the approval Drugs & Biologics FDA Approves At-Home SKYRIZI Start for Crohn's Oct 24, 20267 min read Read the story A close-up of a curved EU institutional building facade against a blue sky, a generic stand-in for EU regulatory policy Guidance & Policy EMA, African Regulators Set Rules for Ebola Trials Oct 24, 20268 min read Read the story A senior pharmaceutical executive in an office setting, a generic stand-in for GSK leadership announcing the approval Drugs & Biologics FDA Approves GSK's Hibsago for Chronic Hepatitis B 6 min read Read the story Nouscom illustration of two viral vaccine vectors carrying DNA, labelled viral genome, tumor neoantigens, viral genome Spotlight Nouscom Raises $135M for Cancer-Prevention Vaccine Oct 22, 20267 min read Read the story A scientist in a lab coat and safety glasses looks into a microscope in a SAB Biotherapeutics laboratory Spotlight SAB Bio Wins FDA Fast Track for Diabetes Drug Oct 22, 20267 min read Read the story A smiling physician in a dark suit, standing in for GSK's leadership announcing the Jemperli rectal cancer approval For Physicians FDA Approves First Immunotherapy for Rectal Cancer Oct 21, 202610 min read Read the story A patient's bandaged hand resting on an infusion-chair armrest, an IV line in place, standing in for Jemperli's intravenous dosing Drugs & Biologics FDA Approves GSK's Jemperli for Rectal Cancer Oct 21, 20266 min read Read the story An ophthalmologist examines an adult patient's eye at a slit lamp during a clinic visit For Physicians FDA Approves Enspryng, First At-Home Thyroid Eye Drug Oct 19, 202611 min read Read the story A senior scientist in a tie uses a pipette with a test tube in a bright laboratory Drugs & Biologics FDA Expands Anktiva to Papillary-Only Bladder Cancer Oct 19, 20266 min read Read the story An instructor in a white coat shows a group of masked medical trainees an airway manikin in a clinical training room, a generic stand-in for clinical and medical-education settings Spotlight Marengo Earns Second FDA Fast Track for Tumor Drug Oct 17, 20265 min read Read the story A smiling woman wearing glasses in a bright home living room, a generic stand-in for a patient managing care at home Drugs & Biologics FDA Approves Enspryng as First At-Home TED Treatment Oct 17, 20266 min read Read the story A clinician in a dark top speaks with a seated patient during a consultation in a bright exam room Drugs & Biologics FDA Accepts First Keytruda Biosimilar for Review Oct 16, 20266 min read Read the story A businesswoman in a navy blazer smiles in an office with a city skyline visible through the window behind her Spotlight Leads Biolabs Wins Second FDA Fast Track for BTC Drug Oct 14, 20269 min read Read the story A team stacks hands together over a conference table in a gesture of shared success Drugs & Biologics AbbVie's Temab-A Wins Two FDA Breakthrough Tags Oct 13, 20265 min read Read the story A smiling executive in a navy suit stands in a bright, modern office Spotlight TRexBio Raises $117M in Nasdaq IPO for Treg Drug Oct 11, 20266 min read Read the story A regulatory team briefing stands around a whiteboard in a bright office Guidance & Policy FDA Finalizes Biosimilar Manufacturing-Change Rules Oct 10, 20266 min read Read the story A smiling physician in a white coat and glasses, in a plain studio setting For Physicians FDA Approves First Adjuvant Immunotherapy for Colon Cancer Oct 9, 20269 min read Read the story A physician in a white coat reviews information on a tablet For Physicians MHRA Approves First Drug for Malignant Ascites Oct 8, 20269 min read Read the story A scientist in a lab gown examines samples at a lab bench with a microscope and glassware Drugs & Biologics MHRA Approves Korjuny, a Revived Ascites Antibody Oct 8, 20266 min read Read the story Two colleagues review and sign paperwork together at an office table Drugs & Biologics Alvotech Wins FDA Nod to Double Simlandi Production Oct 5, 20265 min read Read the story A scientist examines a sample under a microscope in a bright laboratory For Physicians Daiichi Sankyo, Merck Pull Lung Cancer ADC Filing Oct 4, 20269 min read Read the story A domed state capitol building photographed from the lawn under a clear blue sky Drugs & Biologics FDA Advisers Back 2027 Flu Vaccine Strains, 9-0 Oct 2, 20265 min read Read the story Gloved hands hold two apothecary jars of capsules and tablets Drugs & Biologics FDA Approves Teva's Denosumab Biosimilar to Xgeva Sep 30, 20266 min read Read the story A physician in a white coat and scrubs writes in a notebook beside a stethoscope and a tablet For Physicians FDA Approves First Drug for Relapsing Nephrotic Syndrome Sep 28, 20267 min read Read the story Three senior executives review printed charts and a laptop together at a conference table Spotlight ADARx Prices $446M IPO to Fund Onvuzosiran Sep 28, 20267 min read Read the story A nurse holding a tablet consults with a colleague in a bright white clinic hallway Drugs & Biologics FDA Approves Gazyva for Childhood Nephrotic Syndrome Sep 28, 20266 min read Read the story A team reviews charted figures and percentages on a whiteboard during an office planning session For Physicians FDA Label Now Backs Early Winrevair Use in PAH Sep 27, 20267 min read Read the story A man in a navy suit sits at a long boardroom table, writing notes in a leather portfolio beside a row of water bottles Spotlight BigHat Biosciences Lands $75M for AI Antibodies Sep 25, 20266 min read Read the story Three colleagues in white shirts share a laugh around a desk with laptops and notebooks open Drugs & Biologics MHRA Approves Lurbinectedin Combo for Lung Cancer Sep 25, 20265 min read Read the story Two researchers in lab coats and nitrile gloves examine flasks of colored liquid during a laboratory review Drugs & Biologics FDA Expands WINREVAIR Label With HYPERION Data Sep 23, 20266 min read Read the story A gray-haired executive in a blazer smiles while reviewing bar and line charts on a printed report Spotlight Electra Therapeutics Prices $350M IPO for sHLH Drug Sep 22, 20266 min read Read the story 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 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 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 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 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