Regulation

Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data

CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.

An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.

Subcutaneous BRIUMVI hit MCID in 82% of myasthenia gravis patients at Week 24, prompting a potentially registration-directed Phase 2 sequential-therapy trial.

The Cambridge biotech has initiated its pivotal NORTHSTAR study of oral gildeuretinol in Stargardt disease, with no approved treatment currently available.

The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis

Artiva Biotherapeutics secured RMAT designation for its allogeneic NK cell therapy after Phase 2a data showed durable responses in refractory rheumatoid arthritis.

New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.

All 12 patients in a UChicago Medicine pilot achieved insulin independence, with mean HbA1c of 5.4% and no severe hypoglycaemic episodes post-transplant.

A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.

RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI

China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.

Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.

Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight

PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.

Boehringer Ingelheim's glucagon/GLP-1 dual agonist met primary endpoints in two Phase III trials, with lean mass largely preserved, data published in NEJM

The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.

The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.

The European Commission has expanded lomitapide's indication to children aged five and older with homozygous familial hypercholesterolaemia, backed by Phase 3 data.

Topline 12-month efficacy data for CBT-001, a potential first FDA-approved pterygium drug, are expected in Q3 2026.