Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
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 US regulator's designation covers advanced non-squamous NSCLC after anti-PD-(L)1 and platinum chemotherapy, but the company's third-quarter cash position underlines its continuing need for financing.
The MRI-guided cardiac catheterisation company reports its first US sales, two children's hospital customers and extended FDA paediatric labelling in its third-quarter results.
The company's PMA supplement for air and ground transport labelling remains under FDA review, with audit readiness expected in mid-December and agency inspections to follow.
The agency has accepted Intellia's BLA for lonvoguran ziclumeran with priority review and does not currently plan an advisory committee, the company said at an investor event.
The designation covers the Phase 3 DUBLIN-4 population, while BeyondSpring completes the sale of its China-linked subsidiary to Biolin and reports cash of just $0.6 million.
NeOnc will use the early January 2027 meeting to test whether Phase 2a data can back a 505(b)(2) application for NEO100 in recurrent IDH-mutant grade 4 astrocytoma.
The US company expects to resubmit its dexmethylphenidate application between December 2026 and January 2027, after FDA raised manufacturing questions in a June complete response letter.
The EMA committee has recommended extending Novartis' IL-17A inhibitor secukinumab to adolescents with HS who responded inadequately to conventional systemic therapy, pending a European Commission decision.
Health Canada lists a Class II recall of Philips Azurion R3.1 systems after two software issues were found, one causing a reboot loop and one cutting motion power.
Aardvark Therapeutics says the FDA cleared its ARD-101 IND after cardiac safety studies, allowing a 200 mg twice-daily open-label trial, with a development-plan meeting due in Q1 2027.
The EMA committee has recommended obinutuzumab for adults with moderate-to-severe, active SLE despite standard therapy, based on phase III ALLEGORY data; a European Commission decision is expected soon.
The EMA committee has backed obinutuzumab for adults with moderate-to-severe, active systemic lupus erythematosus despite standard therapy, with a European Commission decision expected shortly.
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 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.
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.
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.
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 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.
TMC the metals company reports about $123 million in liquidity and a later NOAA timeline for its USA-A application, after the agency said it must review more than 1,600 public comments.
The company has sent the FDA a briefing document seeking agreement that the nafamostat study can close at the end of 2026 even if fewer than 70 patients are enrolled.
Fractyl Health says its duodenal ablation device hit the co-primary endpoint in weight maintenance after GLP-1 discontinuation, while it restructures and drops Rejuva gene therapy.
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.