FDA delays Corcept’s hypertension drug, seeks more evidence

The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence

FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline

Sinopia Biosciences scores NIH grant to supercharge AI-driven drug discovery

The funding will accelerate Sinopia’s data-driven drug discovery efforts

CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers

The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively

Transcenta teams up with EirGenix to revolutionise biologics manufacturing

Transcenta will grant EirGenix a non-exclusive license to its Highly Intensified Continuous Bioprocessing (HiCB) platform

Harbour BioMed teams up with Lannacheng to advance next-generation cancer therapies

Harbour BioMed brings advanced antibody discovery platforms to the table

US House passes Bill reauthorizing FDA rare disease incentive program

IRLAB launches Phase Ib Trial of IRL757 for Parkinson’s patients with Apathy

The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain

Gilead licenses Assembly Bio's investigational Herpes drugs after positive phase 1b data

Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option

China approves first-in-class TGCT drug, marking global first for pimicotinib