Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Growth in the ADHD portfolio offset an 18% fall in pain products, and the company reaffirmed its 2026 guidance.
The model-informed drug development company narrowed its 2026 revenue growth outlook to 2% to 3% and appointed Grant Peterson as Chief Product Officer.
The US insulation-materials maker booked $15.1 million of incident-related costs and expects restoration of its East Providence facility to finish in the first half of 2027.
The US firm says its pre-meal chewable tablet now has a legalised government certificate, and it plans to begin UAE registration with its distribution partner.
The US device maker reaffirmed its 2026 revenue guidance, lowered its operating expense outlook and began a full commercial launch of its AYON power liposuction handpiece.
The agency has pushed back its decision by three months after treating Agios' reply on a possible REMS as a major amendment, as the firm reported Q3 results and R&D cuts.
The US biotech reported Q3 2026 results, with Novartis milestones of $87.5 million and cash of $582.6 million expected to fund operations into 2029.
The US regulator has accepted Zenas BioPharma's biologics licence application, while the EMA has validated the company's European marketing authorisation application for the same indication.
Akebia reported a $14.4M third-quarter net loss as growth in Vafseo use among dialysis patients failed to offset falling sales of Auryxia.
The US drugmaker now expects LINZESS net sales of $1.20-$1.25bn, while its confirmatory Phase 3 STARS-2 trial of apraglutide in short bowel syndrome continues.
The Breakthrough-designated device's pivotal trial has passed six months of follow-up for all 56 participants, with 12-month data collection expected to finish early in Q2 2027.
The gene therapy developer plans a pre-BLA meeting in Q4 2026 for its Duchenne candidate, while the FDA hold on its MPS II programme remains in place.
Dyne Therapeutics reports a PDUFA date for its Duchenne muscular dystrophy BLA alongside one-year myotonic dystrophy data, a wider third-quarter loss and a cash runway into Q2 2028.
The CAR-T developer says Descartes-08 data in AChR antibody-positive myasthenia gravis are due in the first quarter of 2027, ahead of a planned FDA filing, as it reports Q3 2026 results.
Entrada Therapeutics says ELEVATE-45-201 Cohort 1 met its safety and tolerability objective, with Cohort 2 data for both Duchenne programmes expected in the first half of 2027.
The US antibody developer says its 2026 data guidance was met, with an ITP update due at ASH in December and further data planned for 2027.
The US cell therapy developer expects registrational myositis data in the second half of 2027 and has opened a systemic sclerosis cohort, with cash of $299.4 million.
Climb Bio's Q3 2026 update reports sustained APRIL suppression at 12 weeks for CLYM116, a Phase 2 IgA nephropathy start, and cash expected to last into H2 2028.
An independent safety board found no serious adverse events in the first PBGENE-DMD patient through week eight and endorsed treating more patients in Part 1 of FUNCTION-DMD.
Amylyx reported positive Phase 3 LUCIDITY results alongside Q3 figures, saying it will file with the FDA by the end of 2026 for avexitide, which has Breakthrough Therapy Designation.
Amtagvi sales of about $102M in the US drove an roughly 80% year-on-year rise, while UK and Swiss decisions are possible in the first quarter of 2027.
ANI Pharmaceuticals announced a proposed offer for Egetis Therapeutics alongside its third-quarter results, aiming to add EMCITATE to its rare disease portfolio; the deal has not closed.
The animal health company reported third-quarter revenue of $2.4B, with US companion animal sales down 8%, and flagged new FDA actions including a screwworm emergency authorisation for Simparica Trio.
BeOne Medicines reported third-quarter revenue of $1.9bn, with BRUKINSA sales of $1.4bn, and lifted its full-year revenue and operating income guidance.
New ELIMINATE-B results for PBGENE-HBV show undetectable pgRNA and cccDNA reductions at the 0.4 mg/kg dose, with no dose-limiting toxicities or serious adverse events reported.
The US regulator has accepted Palvella's application and set a PDUFA action date of 28 February 2027, with a standalone launch planned for the first half of 2027 if approved.
The gene therapy company reported net income of $35.8 million and positive cash flow, with an EMA marketing application for Papzimeos under review.
The EMA has published the single assessment outcome for the ethinylestradiol/gestodene combination, with a regulatory outcome of maintenance and a list of nationally authorised products.
A manufacturer notice published by Dutch inspectorate IGJ describes how the analyser can place samples from two patients in one IFE block when diluent runs short.
The Dutch inspectorate has published the manufacturer's field safety notice, which links overheating of the °M Warmer to a misplaced seal causing an internal fluid leak.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.