FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Annou ...

The Evidence-Based Drug Policy Act of 2025 seeks to remove federal barriers to researching Schedule I substances like ...

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

As of March 31, 2025, Tonix had $131.7 million of cash and cash equivalents, compared to $98.8 million as of December 31, 2024. Net cash used in operations was approximately $16.6 million for first ...

President Donald Trump signed an executive order on Monday aimed at lowering prescription drug prices in the U.S. Here's what ...

Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat ...

The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” ...

Ireland’s Health and Safety Executive has criticised a new report revealing the country’s shocking last place in Western Europe for new oncology drug access.

IND application submission on track for Q2 2025: MBX 4291, a GLP-1/GIP co-agonist prodrug, is being developed as a once-monthly treatment for obesity. The Company expects to submit an IND application ...

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.

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