Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Arizona Otolaryngology Consultants settled with HHS OIG after self-disclosing that Medicare claims for audiology services were submitted for work done by a non-enrolled individual.
Spain's regulator reports no legislative changes in July–September 2026, but lists a UDI position paper, an IVD classification guidance update and several patient-safety notes.
CATS Consultants GmbH pulled its marketing authorisation application for Qezzaqar on 30 October 2026, before EMA's re-examination of a refusal recommendation was completed.
The EMA committee adopted a positive opinion on 12 November 2026 for Fortvita Biologics' PD-1 antibody, recommending marketing authorisation for adults with non-squamous non-small cell lung cancer.
The EMA committee adopted a positive opinion on 12 November 2026 for Ruxolitinib Krka, a generic of Jakavi, now awaiting a European Commission decision.
The EMA committee adopted a positive opinion on 12 November 2026 for SciencePharma's insulin aspart biosimilar for diabetes mellitus, with a European Commission decision to follow.
The EMA's human medicines committee has recommended marketing authorisation for Fondaparinux sodium Evumed, a generic of Arixtra, across thromboembolism and acute coronary indications.
The EMA committee adopted a positive opinion on 12 November 2026 for a biosimilar fast-acting insulin to treat diabetes mellitus in patients aged one year and above.
EMA's human medicines committee adopted a positive opinion on 12 November 2026 for Baxfendy, an aldosterone synthase inhibitor, for adults whose arterial hypertension remains insufficiently controlled.
The EMA committee adopted a positive opinion on 12 November 2026 for SFL Pharmaceuticals Deutschland's EGFR tyrosine kinase inhibitor, in first-line and T790M-positive advanced NSCLC.
The Slovenian agency has posted the month's safety corrective action notices received from manufacturers and authorised representatives, while warning that the list may be incomplete.
The Danish Medicines Agency has revised the expected period during which a foreign estradiol 25 micrograms/24 hours depot patch can be supplied under section 29(2) of the Medicines Act.
The Danish Medicines Agency has revised the expected period during which foreign-pack estradiol 37.5 micrograms/24 hours depot patches may supply the Danish market under section 29(2) of the Medicines Act.
DKMA's updated notice attributes the shortage of Viatris ApS's 5 mg prasugrel tablets to manufacturer delays, with the disruption running from June 2025 to end-March 2027.
The Danish Medicines Agency says Viatris ApS's Prasugrel Viatris 10 mg tablets face supply difficulties, blamed on manufacturer delays, with disruption expected to run from April 2025 to March 2027.
The Danish Medicines Agency reports manufacturing problems affecting Viatris ApS's frovatriptan 2.5 mg film-coated tablets, with disruption expected from mid-May 2026 to the end of January 2028.
DG SANTE reports positive feedback from sponsors and Member States on the pilot for clinical investigations and performance studies under the MDR and IVDR, with more than 200 attending.
The UK regulator says some services are affected and email is unreliable, but public safety work continues and urgent queries should go by telephone.
The revised guideline covers validation of analytical methods used in residue depletion studies for veterinary drugs in food-producing animals; the changes from the previous version are not stated.
EMA's human medicines committee recommended two lung cancer treatments, a hypertension drug, two insulin aspart biosimilars and two generics, and confirmed two refusals after re-examination.
Austria's regulator relays a Danish notice that European Sperm Bank has blocked the donor's gametes, though use for siblings of existing donor-conceived children remains possible.
The Danish Medicines Agency reports delivery difficulties affecting Ogivri 150 mg powder for infusion concentrate from Biocon Biologics Finland OY, expected to last from late June to late November 2026.
Cases in parts of Aragón and Palencia province may signal changing epidemiology; AEMPS and PRAN point to topical antiseptics and microbiological testing while the national antimicrobial guide is revised.
AEMPS's CODEM-VET issued favourable opinions on seven decentralised-procedure applications at its 11 November meeting; formal authorisation decisions remain pending.
Revision 1 of the EMA reflection paper covers heat inactivation of endogenous retroviruses in live immunological veterinary medicines, though the available material does not say what has changed.
The Danish Medicines Agency attributes the shortage of Sandoz's 75 micrograms/24 hours HRT patch to production problems, with foreign packs permitted as an alternative.
The Danish Medicines Agency expects supply of Sandoz's estradiol patches to be disrupted from October to the end of December 2026 because of manufacturing issues.
Denmark's medicines agency says production problems at Sandoz A/S are disrupting Vivelle Dot 37.5 micrograms/24 hours patches, with foreign packs allowed as a stopgap.
The Danish Medicines Agency has revised the expected period during which foreign packs of estradiol 75 micrograms/24 hours depot patches are needed under section 29(2) of the Medicines Act.
The Danish Medicines Agency says production problems at Perrigo Sverige AB are affecting supply of NorLevo 1.5 mg levonorgestrel tablets, with the expected period running from early to mid-November 2026.
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.