New approvals in the US and EU, label expansions and commercial launches.
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.
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 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.
The US regulator has allowed a Phase 1b study of TBS-2025 in relapsed or refractory mutant NPM1 acute myeloid leukaemia, as TuHURA reports third-quarter results with $1.9 million in cash.
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 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 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.
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.
The US biotech has finished its FDA submission for the CAR-T therapy and is seeking priority review, with a potential 2027 launch.
Nasdaq-listed Quantum BioPharma won approval for a share consolidation of up to 10-for-1 and a name change, and closed a C$80.86 placement of voting shares.
The company, formerly Galapagos, ended September with €2.18B in cash and investments and gave an update on its T-cell engager gamgertamig in autoimmune disease.
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.
Marketing authorisation to Zentiva k.s.; Generic
The agency extended its review of the BLA after classing August's two-year HOPE-3 data and a narrower upper-limb indication as a major amendment, as Capricor reported a wider third-quarter loss.
Inovio says the US regulator cleared its DNA medicine, used with the CELLECTRA 5PSP device, to reduce surgery frequency in adults with the rare airway disease.
The company's CEO said in a media interview that outstanding manufacturing work continues, with resubmission planned as promptly as practicable but no assurance on timing or approval.
The company's Q3 2026 update also confirms a $205M priority review voucher sale and the start of dosing in a Phase 2 facioscapulohumeral muscular dystrophy study.
The US company also reports full enrolment in its OPGx-LCA5 Phase 3 trial and cash of $89.0 million, which it says funds operations into 2029.
The filing rests on skin frataxin as a possible novel surrogate endpoint, with the Phase 3 FORWARD-FA confirmatory trial still enrolling.
The US biotech reported Q3 2026 results, said Part 2c enrolment completes in November, and put its cash runway into the first half of 2028.
The company still intends to seek FDA accelerated approval of tralesinidase alfa for MPS IIIB in December, while restructuring its debt and separating its CRHX-101 programme.
Bayer Healthcare; NDA221291; New molecular entity, Priority review
The hybrid pharma-device company's presentation highlights January 2026 FDA approval for re-administration of iDose TR, new Phase 3 non-inferiority analysis and earlier-stage iDose follow-on products.
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.
Egetis Therapeutics' board has unanimously recommended ANI Pharmaceuticals' SEK 11.25-per-share bid, weeks after the US approval of EMCITATE for MCT8 deficiency.
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.