Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
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.
Finland's medicines agency has set out how mandates for acting on behalf of a company should be prepared, so retail licence applications come from properly authorised representatives.
Summit Therapeutics says the FDA has set a 14 November 2026 PDUFA date for ivonescimab in EGFR-mutated NSCLC, with the regulator requiring statistically significant overall survival.
Mineralys Therapeutics reports a $57.3m third-quarter net loss as the FDA reviews its aldosterone synthase inhibitor NDA, with a PDUFA date of 22 December 2026.
GRAIL says Galleri revenue rose 14% to $37.3 million in Q3 2026, and expects an FDA decision on its multi-cancer blood test by early Q1 2027.
The company's 4 November webcast covered ASH abstracts and preliminary Q3 2026 figures, while its forward-looking statements cite serious FDA concerns raised at a pre-sBLA meeting.
Vir's Q3 update reports Fast Track for its PSMA-targeted T-cell engager in prostate cancer, a Gilead deal worth $90 million upfront, and an imminent hepatitis delta Phase 3 readout.
The US launch of daraxonrasib in previously treated metastatic pancreatic adenocarcinoma brought in $197.6m in roughly five weeks, while a European Commission decision is still pending.
UroGen reported a 35% quarter-on-quarter rise in ZUSDURI net revenue, a narrower loss, and a June 2027 FDA goal date for UGN-103 in low-grade bladder cancer.
The US gene therapy developer also licensed OCU400 for the Middle East and North Africa and reported $84.6 million in cash alongside its third-quarter results.
The US biotech filed its NDA in October 2026 and says a Phase 3 confirmatory trial will start in Q2 2027, while cash runway extends only to mid-Q1 2027.
The Bahamian regulator has granted provisional approval and priority designation to the retinitis pigmentosa gene therapy, as Ocugen reports full Phase 3 enrolment and a BLA target of 2Q 2027.
The company submitted its US biologics licence application on 30 September and expects an FDA acceptance decision by end-November, with a PDUFA date by mid-December.
The agency has accepted uniQure's accelerated-approval application for ifezuntirgene inilparvovec, while the UK MHRA has validated a marketing authorisation application for the same product.
The US company says its oral Factor B inhibitor won Chinese approval in July and that FDA discussions on a US route for PNH are continuing.
The European Commission cleared the two obicetrapib medicines in September, the first approvals worldwide, with partner Menarini planning a German launch by the end of 2026.
Spanish company Difarmed has received a five-year parallel import authorisation for Bayer's Mycohydralin, supplied from Greece as Canesten vaginal tablets 0.5 g.
New guidance describes a risk-proportionate framework for clinical trial authorisation applications relying on non-clinical data generated outside the OECD Mutual Acceptance of Data system.
Germany's medicines and devices regulator has posted an urgent field safety notice from Beaver-Visitec International covering two ophthalmic surgical blade products, with details held in a manufacturer PDF.
The Danish Medicines Agency expects Inlyta 7 mg film-coated tablets from Pfizer ApS to be constrained from early November to early December 2026, citing increased demand.
Ravimiamet (Estonian State Agency of Medicines) published an overview of human medicines marketing authorisations newly granted and renewed/updated in late October and early November 2026. It is a routine administrative listing useful for tracking the Estonian national market status of products, with no specific safety action indicated.
Ravimiamet (the Estonian Medicines Agency) published an overview of newly registered and updated marketing authorisations for human medicines. The title refers to July 2026, but the description refers to late October and early November 2026, so the period covered is unclear. It is a routine administrative listing that is useful for tracking national authorisation status, and the input names no specific products or safety actions.
The company has refiled its epinephrine prodrug sublingual film application with the FDA following January's Complete Response Letter, and plans a Health Canada submission in the fourth quarter.
CBER has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry fulfils the post-approval study requirements attached to the device's Humanitarian Device Exemption approval, SeaStar Medical said.
The company also closed its Phase 3 OptimUM-010 trial in primary uveal melanoma over enrolment problems, as it reported Q3 2026 results and a $1.15 billion cash position.
The US regulator has granted Fast Track status to PIKTOR plus paclitaxel in biomarker-selected endometrial cancer, with Phase 2 PIK-201 topline data expected by the end of 2026.
The company says it will finish its FDA submission shortly and plans a first-half 2027 launch if approved, backed by a priority voucher and $444.0 million in cash.
DG SANTE has published MDCG 2026-6 on clinical evidence for orphan in vitro diagnostics, though the accompanying description refers to a different IVD classification guidance.
Ravimiamet's October overview lists transfers of Diclofex-type spray DICLOFLEX to Giuliani and of MIGARD tablets to Phoenix Labs Unlimited Company.
Estonia's medicines agency has published its monthly overview of safety-related product information updates, covering antimalarials, cancer therapies, an antibiotic, hormonal IUDs, a topical scabicide and growth hormone.
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.