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

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 - ...

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

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 ...

Shares of Cogent Biosciences were higher after the company disclosed what it called positive top-line results from a recent trial of its treatment for certain types of mastocytosis, a rare disorder in ...

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

FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418. PR Newswire. SHANGHAI and SAN DIEGO, May 22, 2025.

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 ...

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 ...

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 ...