One of the most significant biomedical achievements of the 21st century, mRNA vaccines have reshaped the world’s ability to ...

One of the most significant biomedical achievements of the 21st century, mRNA vaccines have reshaped the world’s ability to ...

H-D Feminine Health, announces it has initiated the first randomized, placebo-controlled, double-blinded Phase 3 clinical trial cleared to proceed by the U.S. Food and Drug Administration (FDA) to ...

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

Travere Therapeutics restructures to boost financial health, expands the kidney therapy pipeline, and sees rapid growth for ...

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

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, ...

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.

Patients on a combination of toripalimab and RemeGen's anti-HER2 antibody disitamab vedotin fared better than those on a chemotherapy regimen.