Regulatory Science

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

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.

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.

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

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

The Toronto-listed theranostic company said 12-month Tigris trial data showed a 13.9% absolute mortality reduction versus standard care.

IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.

CG Oncology says PIVOT-006 has accrued most target events, with topline data imminent and a BLA submission for bladder cancer due in Q4 2026.

Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.

Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.

The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.

Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m

IQVIA will provide clinical and regulatory infrastructure to Medera's AAV gene therapy and human cardiac tissue modelling platforms.

The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.

The Santa Clara medtech posted $56m in Q2 revenue and filed a third breakthrough-device application, as adjusted EBITDA rose 178% year-on-year.

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.

MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling