Regulation

ADARx Pharmaceuticals has secured Fast Track designation for its siRNA candidate onvuzosiran, now in Phase 3 trials for HAE prophylaxis.

The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.

Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.

The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.

Humacyte plans a November 2026 supplemental BLA filing to add haemodialysis access as a second approved indication for its bioengineered vessel.

Milestone Pharmaceuticals has enrolled the first patient in ReVeRA-301, a pivotal Phase 3 study of self-administered etripamil nasal spray for atrial fibrillation with

Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.

The European Commission has approved the bispecific-antibody doublet for relapsed/refractory myeloma from second line, backed by Phase 3 survival data.

The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.

Humacyte's peer-reviewed Phase 3 data show its bioengineered vessel outperformed standard fistulas in women and obese or diabetic men on haemodialysis.

The Austin-based biotech said the designation supports its inhaled Caveolin-1 peptide, with Phase 2 interim data expected in the second half of 2026.

Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.

The FDA has accepted Teva's NDA for ecopipam with a PDUFA date in Q1 2027, potentially the first new Tourette's therapy in over

The all-stock deal, backed by a $150m oversubscribed private placement, creates a Nasdaq-listed company targeting the first FDA-approved therapy for CRPS-1.

DataFlow's TrueProfile.io will list 70-plus DHA-accredited CPD/CME courses for verified healthcare professionals across six GCC countries.

Radar Healthcare has bought patient experience platform Cemplicity to link PREMs and PROMs data with its quality and safety workflows.

Pacira BioSciences' intra-articular gene therapy showed durable tolerability and exploratory pain improvements over two years in moderate-to-severe knee osteoarthritis.

Aetna has recognised both implant-free MIGS devices as medically necessary for mild-to-moderate open-angle glaucoma, completing major US payer coverage for Sight

Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.

The Tel Aviv-listed biotech secured an oversubscribed PIPE to take its oral PTH(1-34) tablet through a registrational trial and NDA submission.