Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
The regulator's first list covers products whose global marketing authorisations began between 2014 and 2021, with further additions and periodic updates promised.
The UK regulator's new guidance sets out key regulatory steps for SaMD manufacturers targeting Great Britain and Northern Ireland, from qualification and classification to MHRA registration.
Health Canada lists a Type II recall after replacement monitors shipped without the required VGA cable, so engineers may have fitted cables of unknown origin.
Elutia says a GLP rabbit study of its antibiotic-coated biologic matrix met its endpoints, with no viable MRSA or E. coli recovered, and it plans a Q4 2026 FDA submission.
The US biotech says the agency has agreed the final design of a randomised trial in previously treated chronic myeloid leukaemia, with enrolment due to start before the end of 2026.
Adicet Bio reports Q3 2026 results, with ADI-212 cleared for prostate cancer and prula-cel's lupus nephritis pivotal study in start-up, alongside $100.9 million in cash.
CytomX Therapeutics reported third-quarter 2026 results alongside news that its EpCAM-directed masked antibody drug conjugate holds Fast Track status, with a registrational study possible in the first half of 2027.
Tectonic Therapeutic's Q3 2026 update also reports first patient dosed in the TX45 ALPINE trial, APEX topline data due by end of January 2027, and $234.7 million in cash.
The company reported first sales of its IgA nephropathy therapy after July's accelerated approval and has asked the FDA to convert it to full approval, with an EMA filing planned for early 2027.
The agency has accepted a Class 2 resubmission for the sublingual epinephrine film after a January 2026 Complete Response Letter, according to the company's November 2026 presentation.
The KIT inhibitor faces FDA action dates in GIST, non-advanced and advanced systemic mastocytosis, as Cogent reports $791.1 million in cash for Q3 2026.
The US firm says the FDA cleared its IND for simufilam in tuberous sclerosis complex-related epilepsy in September, as it reported Q3 results and a securities settlement escrow payment.
Intellia's Q3 2026 update confirms FDA acceptance of its hereditary angioedema CRISPR therapy filing, alongside completed MAGNITUDE-2 enrolment and a new loan of up to $400 million.
Armenia's Ministry of Health has authorised Botvymo and Evamplix for previously treated MSS metastatic colorectal cancer, as Agenus reports Q3 2026 results and readies its Phase 3 ROBBIN trial.
The US company reported a $0.7 million third-quarter net loss, alongside Canadian clearance for its oral testosterone and the start of the BLOOM study of LPCN 1154.
The US firm says its pre-meal chewable tablet now has a legalised government certificate, and it plans to begin UAE registration with its distribution partner.
The agency has pushed back its decision by three months after treating Agios' reply on a possible REMS as a major amendment, as the firm reported Q3 results and R&D cuts.
The US regulator has accepted Zenas BioPharma's biologics licence application, while the EMA has validated the company's European marketing authorisation application for the same indication.
The Breakthrough-designated device's pivotal trial has passed six months of follow-up for all 56 participants, with 12-month data collection expected to finish early in Q2 2027.
The gene therapy developer plans a pre-BLA meeting in Q4 2026 for its Duchenne candidate, while the FDA hold on its MPS II programme remains in place.
Dyne Therapeutics reports a PDUFA date for its Duchenne muscular dystrophy BLA alongside one-year myotonic dystrophy data, a wider third-quarter loss and a cash runway into Q2 2028.
The US cell therapy developer expects registrational myositis data in the second half of 2027 and has opened a systemic sclerosis cohort, with cash of $299.4 million.
Amylyx reported positive Phase 3 LUCIDITY results alongside Q3 figures, saying it will file with the FDA by the end of 2026 for avexitide, which has Breakthrough Therapy Designation.
The US regulator has accepted Palvella's application and set a PDUFA action date of 28 February 2027, with a standalone launch planned for the first half of 2027 if approved.
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.
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 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.
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.
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.