First Commercial Sales: Humacyte commenced its commercial launch of Symvess in late February 2025 after the first commercial batch was released by the FDA. The first commercial shipments containing ...

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 ...

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

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

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 ...

We recently compiled a list of the 11 Stocks That Will Bounce Back According To Analysts. In this article, we are going to ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milsaperidone (Bysanti™) for the treatment of acute ...

Delaying Medicare’s ability to negotiate prices on small-molecule drugs until 13 years after FDA approval will decrease the ...

Viatris shares favorable Phase 3 data for contraceptive patch and pain drug, affirms 2025 sales, and raises adjusted EPS ...

The investigational transdermal delivery system, known as Xulane Lo, is designed to deliver 150mcg of norelgestromin and 17.5mcg of ethinyl estradiol per day.