Successful Type B RDEP Meeting confirms FDA alignment on pivotal Phase 3 study designFDA indicates Opus Genetics may submit a BLA based on ...

USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...

Official FDA minutes confirm the previously announced End-of-Phase 2 meeting outcomes and provide additional detail on the planned Phase 3 ...

Patients diagnosed with metastatic pancreatic cancer face some of the bleakest odds in oncology, with most surviving less ...

SYRE is targeting major IBD drug trends with long-acting antibodies and combination therapies, but its future still hinges on ...

RNA interference is a natural mechanism for living cells to control whether specific genes are being used or not.

Jubilant HollisterStier, a CDMO unit of India’s Jubilant Pharmova, earned an FDA warning letter after inspectors found its Montreal production plant lacked appropriate quality control systems. The ...

Official minutes from Alterity Therapeutics’ End-of-Phase II meeting with the US Food and Drug Administration, confirm a ...

The FDA has issued a warning letter to China-based continuous positive airway pressure (CPAP) device maker BMC Medical.

A first-of-its-kind drug may slow the progression of Huntington's disease, a rare, fatal, neurodegenerative disorder.

MIT researchers say that a low-cost electronic nozzle design could produce time-release drug-delivery particles efficiently ...

A Food and Drug Administration advisory panel on Thursday recommended the approval of Moderna’s mRNA-based flu shot for older adults.