Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug ...

Pharma Vet brings 20+ years of Legal, Compliance, and Commercialization Expertise as Company prepares ADHD Drug Filing ...

A new drug targets RAS-PI3Kα pathways without harmful side effects. It was developed using high-performance computing and AI.

- NDA assigned a Target Action Date of February 25, 2026 - ...

Dr. Dave Campbell and Dave Aronberg join Morning Joe to discuss their new book 'Fighting the Florida Shuffle: The Inside ...

Novo Nordisk NOVO.B0.25%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

Shares of Instil Bio jumped after federal regulators cleared the investigational new drug application for its tumor treatment AXN-2510. The stock was up 11% at $24.38 in early trading. Shares were ...

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with ...

Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...

Novo Nordisk said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on ...