Bayer BAYRY announced the submission of a supplemental new drug application (sNDA) to the FDA for darolutamide. The sNDA is ...

Zealand Pharma said it has received a complete response letter from the Food and Drug Administration related to its new drug application for dasiglucagon for the prevention and treatment of ...

Cullinan Therapeutics has filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) for CLN-978 for the treatment of systemic lupus erythematosus (SLE). Continue ...

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a ...

The FDA received an application for Nubeqa as a potential treatment option with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer. A supplemental new drug application has ...

Kymera Therapeutics Announces FDA Clearance of Investigational New Drug Application for KT-621, a First-in-Class, Oral STAT6 Degrader ...

has cleared an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC-1245, a new chemical entity for the treatment of biomarker-enriched solid tumors and lymphoma.

has accepted for filing its New Drug Application (NDA) for sepiapterin, a treatment designed for both pediatric and adult patients with phenylketonuria (PKU). The company expects to receive a ...

AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...

With the Oct. 5 deadline come and gone, the West Virginia First Foundation received a total of 174 grant applications for ...

Ellison Bryde was 17 years old when she died of fentanyl poisoning, her mother Kari Clay said Wednesday during an ...

A change in the application process for state opioid and stimulant response (SOS) grant funding caught the Wood County Alcohol, Drug Addiction and Mental Health Services Board off guard a bit.