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

Titusville: Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug ...

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

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA ...

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

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

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 ...

SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, announced today that the China National Medical ...

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 ...

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

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 ...

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 ...