Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
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.
Geron reported a 5% quarterly rise in Rytelo sales and a small profit, lowered its 2026 operating expense guidance and discontinued its Phase 3 IMpactMF myelofibrosis trial.
The company said it expects to submit the design of its next SER-155 study to the FDA in the first quarter of 2027, with progress dependent on funding.
The company reported third-quarter net revenue of $180.3M and lifted its full-year total revenue outlook, while the FDA approved an oral pellet formulation of ORLADEYO for hereditary angioedema.
Seres Therapeutics' corporate presentation cites FDA agreement on study design for SER-155 in allogeneic transplant recipients, alongside Phase 1b data and an earlier-stage checkpoint inhibitor programme.
Nine lots of the apple-flavoured veterinary powder are affected by a defect that may compromise container closure integrity, with national distribution down to retail level.
The agency's CY 2027 final rule, CMS-1848-F, amends the Medicare Shared Savings Program with the aim of speeding up accountable care and linking spending to value.
The US agency has finalised Medicare payment policy changes and other Part B issues taking effect on or after 1 January 2027, though provision-level detail is not yet available.
The US agency says the final rule moves Medicare payment emphasis towards preventive care and away from treating illness, while curbing waste; provision-level detail is not yet clear.
The Medicare final rule sets 2027 hospital outpatient and ASC payment rates, widens outpatient surgery options and lowers beneficiary out-of-pocket costs for certain services.
The US Centers for Medicare & Medicaid Services published rule CMS-1850-F on 4 November 2026, setting Medicare outpatient payment policies and rates for calendar year 2027.
The US Centers for Medicare & Medicaid Services published final rule CMS-1844-F on 4 November 2026, setting annual Medicare payment policy updates for home health agencies.
The US agency says the final rule strengthens its authority to recover Medicare payments, clarifies home palliative care access and accelerates public quality reporting, with savings expected in the tens of millions of dollars.
The German regulator has posted a manufacturer notice covering the Electric 2, Rapid 2 and Scrambler 2 handbike attachments, though the hazard and required actions are not stated in the listing.
Germany's BfArM has posted a manufacturer field safety notice for Hologic's Horizon DXA bone densitometry system, but the nature of the problem is only in the attached Advisory Notice.
CBER's pilot under HHS Operation TrialBlazer will test whether outside expert institutions and rolling review can speed first-in-human trials without lowering safety or oversight standards.
FDA's biologics centre says sponsors in the pilot will submit discipline-specific components during pre-IND development, with a QRI vetting each one before the 30-day review begins.
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.
New guidance explains when UK trial applications relying on non-OECD MAD safety data may be considered, including enhanced assessment in limited circumstances and a programme of test facility inspections.
Italy's medicines agency says registry users can now select ranibizumab product RANLUSPEC in the simplified multi-drug form for intravitreal anti-VEGF treatments, covering four eye-disease indications.
From 4 November 2026, Italy's XOSPATA (gilteritinib) registry eligibility form lists quizartinib among earlier treatments that do not rule out gilteritinib use in relapsed or refractory FLT3-mutated AML.
The Danish Medicines Agency says Teva Denmark's bendroflumethiazide and potassium chloride tablets are affected by increased demand, with only a partial delivery of 100 packs expected in early October.
From 4 November 2026, registry users can select Ranluspec (ranibizumab) in AIFA's simplified multi-drug intravitreal anti-VEGF monitoring form, following Determination Pres/1459/2026.
From 4 November 2026, the eligibility form for gilteritinib in FLT3-mutated relapsed or refractory acute myeloid leukaemia lists quizartinib among permitted earlier treatments.
Italy's medicines agency explains how companies receive paper GMP measures by registered post and points to earlier notices governing digitally signed documents and online submissions.
Germany's BfArM has published a manufacturer field safety notice for Urotech GmbH's Flexible Injection Needle, but the listing itself does not set out the problem or the required actions.
Germany's regulator has posted a Medline International France SAS field safety notice on sterile OP-Abdecktücher, but the listing itself gives no details of the defect or affected lots.
Germany's federal regulator has published a manufacturer notice on SOPHIE, but its listing does not state the issue, affected devices or required actions.
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.