The FDA's Vaccines and Related Biological Products Advisory Committee was scheduled for next month. But the agency notified committee members that the meeting had been canceled.

Because price and margin headwinds exist predominantly in small-molecule oral tablets that are easy to produce, we expect Viatris’ future pipeline to focus more on complex generics—drugs that have ...

Artificial intelligence improves process control and reduces the time required to produce key products such as the COVID-19 ...

PRGN-2012—which Precigen has begun to call by its generic name of zopapogene imadenovec—is a gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus ...

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Grin Therapeutics’ radiprodil for ...

In this week’s edition of InnovationRx, we look at Eli Lilly’s weight-loss pill stockpiling, scaling stem cell manufacturing, ...

NewsMedical speaks with CN Bio about the translatability between in vitro organ-on-a-chip (OOC) models, microphysiological ...

Entrada Therapeutics can plough on with the development of its Duchenne muscular dystrophy (DMD) therapy, ENTR-601-44, now ...

A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...

This collaboration with ORA represents a major milestone in DIAGNOS’ expansion strategy. With extensive experience in guiding ophthalmic products through regulatory approvals, ORA will play a pivotal ...

Adial Pharmaceuticals (ADIL) announced a “positive” response from the U.S. FDA regarding its proposed in vitro bridging strategy for AD04. The ...