Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
The FDA has accepted Intellia's BLA for the one-time in vivo gene-editing therapy lonvoguran ziclumeran, with a PDUFA date of 10 March 2027 and no advisory committee currently planned.
The US biotech says SOLARA-2, a single-arm study in EGFR C797S-positive NSCLC, should dose its first patient in Q1 2027 and could support an accelerated approval filing.
Eledon reports Q3 2026 results, with US regulatory milestones in islet cell and kidney transplantation and $69.7 million in cash funding operations into Q2 2027.
The designation covers metastatic pancreatic adenocarcinoma, as Erasca reports $947.8M in cash at Q3 2026 after a July public offering of about $632.5M.
Armata Pharmaceuticals also reported Q3 2026 net income of $54.9 million, driven by a loan fair-value gain, while it finalises its Phase 3 protocol with the FDA.
Candel Therapeutics now expects to file its aglatimagene besadenovec application in mid-2027, citing assay refinement timelines, and reports cash of $203.1 million.
The agency has approved a PMA supplement for the CGuard Prime 80 cm system in TCAR for high-surgical-risk patients, based on the 50-patient CGUARDIANS II trial.
The US cell therapy and devices company says it has completed the PMDA process on CardiAMP application materials, while FDA feedback on a revised Helix Pre-Submission is expected within weeks.
The US device maker reported Q3 2026 results, with FDA clearance for transcarotid use, a PMA supplement planned for December and a recalled delivery system due back in 2027.
Siemens Healthineers is issuing a delta-installation hotfix, XB20A-HF02, for seven MAGNETOM Flow.Elite scanners in Canada, addressing coil detection, logging, start-up stability and patient table reliability.
Health Canada has listed a recall of Centricity Universal Viewer software over a vulnerability that could allow unauthorised access to patient data when launched from third-party applications.
Siemens Healthcare's syngo MR XB10B-HF02 hotfix, covering two MAGNETOM Flow.Elite systems in Canada, addresses coil detection, data logging, start-up stability and patient table reliability.
Lab tests found Sphingomonas bacteria in an injectable peptide seized from Sage & Summit Wellness Co., and the regulator lists ten unauthorised injectable and oral products.
PolyPid says the FDA is reviewing D-PLEX100 for preventing surgical site infections in colorectal surgery, while the EMA has validated its marketing authorisation application and European rights have reverted to the company.
MeiraGTx says its dossier for the X-linked retinitis pigmentosa gene therapy is complete, with a European filing planned for December 2026 and a US submission early next year.
The company says Type A meeting minutes cited no clinical safety or efficacy deficiencies, and a $10M private placement extends its cash runway through 2028.
The US biotech has finished its FDA submission for the CAR-T therapy and is seeking priority review, with a potential 2027 launch.
Monopar Therapeutics says it expects to finish its rolling FDA submission for ALXN1840 within weeks, reporting $129.4 million in cash that it says funds operations through at least March 2028.
The Rett syndrome gene therapy developer says validation batches met specifications, with an FDA CMC meeting due this quarter and BLA-pathway feedback expected in the first half of 2027.
Belite Bio says the FDA will not convene an advisory committee for its Stargardt disease type 1 application, as filings also proceed in Japan and through the Access Consortium.
Pharvaris reported Q3 2026 results, with the FDA reviewing its NDA for on-demand deucrictibant IR and the EMA assessing the matching marketing authorisation application.
The company reported updated LEGEND Cohort 1 data in BCG-unresponsive high-risk NMIBC with CIS and said it agreed the efficacy-evaluable population with the FDA.
Beaver-Visitec International says certain units may have an open seal that cannot guarantee sterility, according to a field safety notice published by the Dutch inspectorate IGJ.
A decision of 12 November 2026 extends the list under Article L. 5126-6, 1° of the Public Health Code with an anticancer, an antiviral and a multiple sclerosis capsule.
Austria's BASG summarises the CHMP's 12-15 October meeting, which recommended new products for obesity, type 2 diabetes, pancreatic cancer, glioma and achondroplasia, plus several extensions of indication.
Austria's BASG has published its summary of the CHMP's September 2026 meeting, listing seven therapeutic areas with positive opinions and four new medicines described in detail.
The IGJ has released an inspection report on Campro Scientific GmbH's Veenendaal site, but the material available does not set out the findings or any required improvements.
France's medicines agency has refreshed its regional list of hospital and community pharmacies with at least one trained pharmacist authorised to order and dispense medical cannabis under the experimentation.
The UK regulator has posted its second-quarter performance report and an accompanying letter, extending a quarterly transparency series first published in August.
Portugal's regulator has issued Deliberation 110/CD/2026, extending temporary export suspensions to protect supply of critical medicines, exceptional-use products, and all quetiapine oral solids and estradiol medicines.
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.