Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
A six-month pilot with seven studies found benefits in drawing up a plan at study design, while the HRA refines guidance ahead of a 12-month voluntary phase from early 2027.
The final guidance sets out FDA's recommendations for HBV testing of Whole Blood and blood components, including Source Plasma, and replaces several older memoranda.
The US regulator has issued final guidance setting out a quality-risk-management approach to potency across the lifecycle of cell and gene therapies, replacing the December 2023 draft.
NRx says the agency cleared its ANDA for ketamine injection without benzethonium chloride, made by blow-fill-seal at Nephron, as a long-running shortage continues.
Inovio's first product, Voceryq (INO-3107), is approved to reduce surgery frequency in adults with RRP, with continued approval potentially contingent on confirmatory study results.
The agency has accepted the accelerated approval application for AMT-130 and tentatively plans an advisory committee discussion, with a decision due by 1 May 2027.
CBER's recommendations describe how blood establishments may reevaluate donors who are initially reactive for hepatitis B surface antigen, provided other suitability requirements are met.
The regulator refreshed its published list of products with a Traditional Herbal Registration on 2 November 2026, but the page does not say which products changed.
CBER's final guidance sets out a science- and risk-based approach to potency assurance for CGT products and supersedes the January 2011 potency tests guidance.
CBER's final guidance sets out a risk-based Potency Assurance Strategy for CGT products, covering development through post-market verification and superseding the agency's 2011 potency testing guidance.
The UK regulator updated its published list of herbal medicines with a traditional herbal registration on 2 November 2026, with the document now a 33-page PDF.
The Dutch health inspectorate has published a manufacturer field safety notice on a heating element time-out error affecting bioMérieux EMAG systems already running the SP4 Patch version 2.
Austria's latest RMS NEWS reports updated CMDh validation advice, revised RMS request templates for DCP and MRP/RUP, and national requirements now tagged as validation-relevant or not.
Germany's Paul-Ehrlich-Institut has published a Dear Healthcare Professional letter warning that Respreeza's primary container may be compromised, risking missed doses and infections.
CBER has cleared Inovio's Voceryq for adults with RRP on a surgery-frequency endpoint, with post-approval trials required to confirm clinical benefit.
The Medical Device Coordination Group has issued a revised position paper on managing the Summary of Safety and (Clinical) Performance in Eudamed once the system's use becomes mandatory.
The UK regulator has authorised an oral liquid triheptanoin for adults and children with LC-FAOD, pending further efficacy and safety evidence from an ongoing paediatric study.
The guidance, issued through CBER and CDER, outlines a nonclinical testing strategy for QT-related risk, including assays and integrated risk assessment, and may be revised as data accumulate.
Italy's medicines agency says problems with automatic mapping of EudraVigilance ICSRs to its national network prompted a reminder on completing two key E2B(R3) fields uniformly.
The medicines agency says Lenzetto spray should return progressively from mid-November, while some transdermal patches stay hard to obtain because of demand pushed up by the shortage.
Italy's medicines agency says problems with automatic mapping of EudraVigilance cases to its national network prompted a reminder on how to complete product name and active substance fields.
The Paul-Ehrlich-Institut has let STADA supply Hukyndra 40 mg pre-filled pens in Finnish, Swedish, Norwegian and Danish packs in Germany to secure patient supply.
AEMPS's Veterinary Medicines Availability Committee updated its priority-needs document, adding new active-substance needs and removing others now covered by authorised products.
The UK regulator has widened Casgevy's licence from patients aged 12 and over to eligible younger children with severe sickle-cell disease or transfusion-dependent β-thalassaemia.
The agency has reissued its draft guidance on delivery performance information for drug-delivery devices and combination products, replacing the version announced in July 2024.
Estonia's State Agency of Medicines (Ravimiamet) announced that, by decision of its Director General, changes were made to the register of activity licences (manufacturing/wholesale authorisations) in October 2026. The input does not specify which licences were affected, so QA professionals should check the register directly for any impact on their supply chain partners.
Biohaven says the US regulator has treated its troriluzole resubmission as a complete response to the November 2025 action letter, with an advisory committee planned.
Stoke says its FDA meeting covered analysis of a cognition and behaviour secondary endpoint in the Phase 3 EMPEROR study, with topline data due in Q3 2027.
Subsidiary Cyclo Therapeutics has submitted an NDA and requested a rare pediatric disease priority review voucher, although the TransportNPC trial did not meet its primary endpoint overall.
The EphA2-targeting Bicycle Drug Conjugate received the US designation in September 2026, while the company reported $469.9 million in cash and a $10.5 million third-quarter net loss.
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.