FDA has cleared an investigational new drug (IND) application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune conditions. Patient ...

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal ...

BrainStorm has attempted to gain market approval for NurOwn without success but remains committed to developing the cell therapy.

The FDA granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.

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

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 ...

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

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary ...

The Ontario Institute for Cancer Research (OICR) has announced its support for five Ontario research teams working to develop the next generation of medicines that kill tumours more effectively, cause ...

“Moving forward to investigational new drug application-enabling studies and human clinical trials, it can cost tens of millions of dollars,” Wang said. “That's basically beyond what we can do in ...

(RTTNews) - Milestone Pharmaceuticals (MIST) announced the FDA issued a Complete Response Letter regarding its New Drug Application for CARDAMYST nasal spray, a prescription medication in ...