The US Food and Drug Administration (FDA) has granted clearance to CureVac's investigational new drug application (IND) for ...

In Actavis Labs. FL, Inc. v. U.S.  (“Actavis”), a recent precedential decision, the Federal Circuit answered an important ...

Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...

From my colleague Allison DeAngelis: Over the last few years, the drug industry has rushed to retool CAR-T treatments for ...

A surge of generics, biosimilars, and innovative therapies is expected in 2025, addressing conditions from cancer to chronic ...

As with its predecessor, the new drug candidate, Jun13296, targets a different viral protein than Paxlovid does and works ...

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...

Corcept's relacorilant hits phase 3 trial success in ovarian cancer, lifting shares 90%. Click here to find out why I rate ...

FDA reviews TNX-102 SL for Fibromyalgia by August 2025, with no advisory required. See why we recommend a buy on TNXP stock.

The topical ocular drug is an investigational new drug candidate that requires more well-controlled studies to establish ...

CERo Therapeutics (CERO) announces that the Company has received clearance by the U.S. Food and Drug Administration, FDA, for a second ...

Menopause-related health problems, both physical and mental, have become a pressing issue for women at the transformative age ...