In a significant milestone for Syndax, the U.S. Food and Drug Administration (FDA) granted approval for two of the company’s key drugs. Revuforj received the green light for the treatment of Acute ...

Amgen and Kyowa Kirin Co., Ltd. (Kyowa Kirin) announced new results from the ongoing ROCKET phase 3 clinical trial programme evaluating rocatinlimab, an investigational T-cell rebalancing therapy ...

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical ...

Bristol-Myers Squibb is trying again to get approval for its checkpoint inhibitor combination of Opdivo and Yervoy in previously-untreated non-small cell lung cancer (NSCLC), which right now is ...

The products are expected to be available in June 2025. Osenvelt is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid ...

Reproxalap, a first-in-class small-molecule modulator of reactive aldehyde species (RASP), is under review for the treatment of the signs and symptoms of dry eye disease. It works by covalently ...

The Launch-HTN trial showed lorundrostat 50 mg reduced systolic blood pressure by 16.9 mmHg, with a placebo-adjusted reduction of 9.1 mmHg. The Advance-HTN trial showed lorundrostat 50 mg achieved ...

Three months after an FDA approval for cancer immunotherapy Unloxcyt, Checkpoint Therapeutics has found a buyer. Sun Pharma has agreed to purchase the Massachusetts biotech for an upfront value of ...

With a U.S. green light for its encapsulated cell therapy technology in the bag, privately held biotech Neurotech Pharmaceuticals is on the verge of making its commercial debut. The FDA last week ...

Mission Barns, a startup growing animal fat in proprietary bioreactors it claims can dramatically improve the efficiency of the production process, has secured an FDA ‘no questions’ letter regarding ...