In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...

Kymera Therapeutics received clearance from the Food and Drug Administration for its investigational new drug application of KT-621. The clinical stage biopharmaceutical company said it expects to ...

Kymera Therapeutics, Inc. KYMR announced that its investigational New Drug (IND) application for pipeline candidate, KT-621, has been cleared by the FDA. KT-621 is an investigational first-in-class ...

A slate of popular policies commonly bandied about to help reduce drug costs would each cut average prices by only a handful of percentage points, according to a recent Congressional Budget Office ...

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 ...

Bayer announced today that the FDA has accepted their new drug application (NDA) for menopause drug, elinzanetant, to treat ...

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

Magdalena aiming to submit Investigational New Drug (IND) application in early 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications ...

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

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

The FDA's Tala Fakhouri discusses the agency's approach to the regulation of AI in clinical trials in a new interview.

CLD-101 is a novel stem cell-based treatment that delivers oncolytic viruses to tumors, which may benefit patients with newly ...