Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug ...

Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

Vadodara: Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug ...

Lupin receives US FDA approval for rivaroxaban tablets USP, 10 mg, 15 mg & 20 mg: Our Bureau, Mumbai Thursday, May 15, 2025, 15:40 Hrs [IST] Global pharma major Lupin Limited (Lup ...

The FDA has cleared the IND for Ensoma's EN-374, targeting X-linked chronic granulomatous disease (X-CGD), a rare genetic ...

Cytokinetics' PDUFA date for aficamten was extended to December 26th of 2025, due to the FDA's need to review a submitted ...

The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug ...

MPox is endemic in DRC, and has continued to cause large numbers of cases in the WHO African Region. In April, 2025, the WHO has restated that MPox continues to be a Public Health Emergency of ...

Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world's first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) ...

The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.

There could be an upside to incorporating AI for the FDA. Using AI to assist in final drug reviews would "represent a chance ...

Few areas of healthcare are as sensitive as cancer treatment. Each year, around 44,000 cancer tumours are diagnosed here.