Merck (NYSE:MRK) and Daiichi Sankyo (OTCPK:DSNKY) (OTCPK:DSKYF) announced Thursday the voluntary withdrawal of their U.S.

The BLA seeking accelerated approval for patritumab deruxtecan in previously treated, locally advanced EGFR-mutated NSCLC in ...

After Merck paid a hefty sum to co-develop and co-commercialize HER3-DXd, the drug has suffered notable setbacks in ...

Savara (NASDAQ:SVRA) announced Tuesday its plans to meet with the U.S. FDA after the regulator issued a refusal to file (RTF) ...

Intellia reports a grade 4 liver enzyme elevation in a Nex-Z trial patient; no hospitalization is required, and enrollment ...

Candel Therapeutics stock rose after its prostate cancer therapy, CAN-2409, received FDA RMAT designation. This expedites ...

Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter ...

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN) in adults.

Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active ...

The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...

Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE ® FL-1 trial Full results from the trial will be ...