The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the ...

The FDA accepted vepdegestrant’s new drug application for ER+/HER2–, ESR1-mutated advanced breast cancer with a June 5, 2026, ...

The U.S. Food and Drug Administration has approved Insmed's oral drug for a type of lung disease, the company said on Tuesday ...

Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for GTx-104 Seeking Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) ...

Monopar Therapeutics Inc. ('Monopar” or the 'Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, ...

Zydus Lifesciences exceeded expectations in the June quarter with a 6% revenue growth to ₹6,573 crore and a net profit of ...

Amphastar Pharma’s iron sucrose injection receives US FDA approval to treat iron deficiency anaemia in patients with CKD: Rancho Cucamonga, California Tuesday, August 12, 2025, ...

The NDA for the gonorrhea indication is supported by data from the EAGLE-1 study, which compared the safety and efficacy of oral gepotidacin to a standard of care combination.

Travere Therapeutics has successfully executed a significant restructuring to recover from previous setbacks and improve its ...

An Durban alleged drug dealer has suffered another setback after his appeal challenging the denial of his release on bail was ...

With a landmark U.S. approval Tuesday, Insmed is making waves with a new class of drug that’s also the first to be green lit ...