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

Difficult. Impossible. Agonizing. Worse than voting in the national election. | Difficult. Impossible. Agonizing. Worse than ...

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 ...

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

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 ...

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

Aldeyra Therapeutics has resubmitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for topical ...

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

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

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