Regulation

The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.

Roche's Krascendo 1 study showed divarasib improved both progression-free and overall survival versus sotorasib or adagrasib in previously treated KRAS G12C lung cancer

LENZ Therapeutics has licensed VIZZ to Australia's largest pharma distributor, marking its fifth international partnership for the FDA-approved presbyopia eye drop.

Atea has fully enrolled its 880-patient global HCV trial, with topline data from the head-to-head DAA study expected around year-end 2026.

The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.

The European Commission has granted orphan drug designation to ABO-101, a CRISPR-based gene editing therapy for primary hyperoxaluria type 1.

The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.

The Paris-based MedTech has combined a €30m Series D2 with a €30m EIB facility to fund US commercialisation of its FDA-cleared polymer repair

Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.

HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.

The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial

Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of

Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero

Germany's BfArM has cleared Silexion's siRNA candidate SIL204 for a Phase 2/3 trial in locally advanced pancreatic cancer, with first dosing expected

BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.

The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.

Stockholm3 detected 90% of aggressive prostate cancers versus 52% for standard PSA testing in a large population-based screening trial published in Annals of Internal

Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.

USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.

Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.