Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The Dutch inspectorate has published a manufacturer field safety notice after routine quality checks found isolated contamination in several lots of Greiner's CRYO.S 2 ml tubes.
Janssen's subcutaneous amivantamab product is cleared for HNSCC after platinum chemotherapy and immunotherapy, based on a 42% response rate in 102 patients, with confirmatory studies required.
The US agency has issued proposed rule CMS-3484-P, titled 'Cutting Administrative Requirements for Excellence in Patient Care (CARE)', but the details are not yet clear from the material available.
The US agency has set lasting policies for negotiating prices of high-cost drugs under Medicare, giving manufacturers more predictability for prices taking effect from 2029.
The US Centers for Medicare & Medicaid Services has issued a final rule covering both the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Benefit Program.
Germany's BfArM has listed a manufacturer advisory from Funke Medical GmbH on its Matratzenverlängerung, but the public entry gives no detail on the problem or the corrective action.
The German regulator has posted a manufacturer notice on the spinal surgery instrument, but its own entry gives no detail on the defect, affected lots or required actions.
Heriberto Rivera received 13 months and Laurent Cassagnol 6 months for a bribery conspiracy that sent VA Community Care patients to an Orlando clinic.
Portugal's medicines authority has published the public funding assessment report for nonacog beta pegol, which is now authorised for hospital use in young haemophilia B patients.
Hungary's public health institute says the 2026/2027 influenza vaccine is at GP practices nationwide, free for people aged 60 and over and defined risk groups, with priority access until the end of November.
The Czech medicines agency will move searching and public file inspection into ASTERx, replacing Verso and the existing case overview, with a new DSŘ II interface for automated access.
The French regulator's 23 October 2026 decision cites rules on shortage notification for medicines of major therapeutic interest, following a risk declaration and an inspection in 2025.
The UK regulator says it will involve patients earlier, reach more diverse communities and show how their input shapes decisions, with NICE collaboration to cut duplicated evidence.
The UK regulator's new corporate plan sets out how patients, carers and the public will be involved in its decisions, building on the 2021-2025 strategy.
Kyle Diamantas says the agency approved 28 novel rare disease drugs and biologics in the past year, while nearly 95 percent of patients still lack an approved treatment.
Czech regulator SÚKL has published a marketing authorisation holder's letter to operators on a vial closure defect affecting CSL Behring's Respreeza 1000 mg.
From November 2026, FAST-EU covers substantial modification requests needed to meet conditions set in clinical trial authorisations, INFARMED reports, with Portugal in 13 of 38 selected trials.
JAZMP has issued a professional recommendation for moving patients from Lenzetto transdermal spray to Estradiol Besins transdermal gel, prepared by clinicians at University Medical Centre Ljubljana.
JAZMP says version 01.13.00.00 of the Android app displayed mg/dL instead of mmol/L; the manufacturer has issued a corrected release, 01.13.01.00.
The Danish Medicines Agency says pre-filled syringes of CAPVAXIVE from MSD Danmark are affected, with disruption expected from early to late November 2026 due to increased sales.
DKMA says production problems at Ceva Animal Health A/S are disrupting supply of the 10-tablet pack, with availability expected to be affected from early November to early December 2026.
The Danish Medicines Agency reports production problems affecting Amoxival Vet. 200 mg tablets (20-pack), with supply expected to be disrupted from early November 2026 to early January 2027.
The Danish Medicines Agency expects disruption to the veterinary antibiotic from early November to early December 2026, citing production problems at Ceva Animal Health A/S.
Spain's medicines agency has published an informative circular on the prescribing, dispensing and use conditions for botulinum toxin medicines when used for aesthetic purposes.
Three batches of Tropicamide 1% single-dose eye drops carry an expiry date of April 2027, but the correct date is 31 October 2026, the MHRA says.
The MHRA has issued a Class 4 defect notification for Sandoz's 250/62.5 mg/5 mL co-amoxiclav oral suspension after its SmPC dosing table was found to be wrong, with all batches affected.
The Danish Medicines Agency says Elanco's live infectious bursal disease vaccine for drinking water is in short supply, with disruption expected from mid-September to mid-December 2026.
The Danish Medicines Agency says supply of Elanco's live attenuated infectious bursal disease vaccine is expected to be disrupted from late September to mid-December 2026.
A Class 4 defect notice says the weight-based dosing table in Sandoz's co-amoxiclav 250/62.5 mg/5 ml SmPC is wrong, and the document has been withdrawn from MHRA and eMC websites.
A survey open until 26 February 2027 asks developers, clinicians, researchers and the public how Phase 1 resources from the Wellcome-funded DMHT programme have been used.
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.