Duality Biotherapeutics' ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation ...

Delhi has long stood as a beacon of modern healthcare. The national capital is home to gleaming hospitals, internationally ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England Journal of Medicine on May 20 requiring a stronger evidence base for boosters ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...

Sotatercept-csrk was first approved in 2024 to treat pulmonary arterial hypertension (PAH) in adults based on results seen in the phase 3 STELLAR trial.

Gene editing stocks were largely steady in the premarket on Friday after the FDA’s CBER unit faced another abrupt leadership transition. Read more here.

The realignment within the U.S. FDA continued with reports of the removal of two high level executives. When asked by BioWorld if the Center for Biologics Evaluation and Research’s (CBER) Office of ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, the agency is investigating two Duchenne muscular dystrophy patient ...

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.