The FDA has granted fast track designation to 4P004, a GLP-1 agonist analog, for the treatment of knee osteoarthritis, ...

CIPN is a common nerve-damaging side effect of chemotherapy with no FDA-approved treatment optionsFast Track designation ...

Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage ...

FDA fast track designation enables increased regulatory interaction and potential rolling BLA review for RPTR-1.201 in ...

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track ...

The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...

Tazbentetol, an experimental oral therapy for ALS, received FDA fast-track designation. The treatment promotes synapse formation to restore nerve cell communication. A Phase 1/2a trial showed ...

Since it was established nearly a year ago by the FDA, the Commissioner’s National Priority Voucher (CNPV) program has been ...

FDA fast track designation supports development of pelareorep plus bevacizumab/FOLFIRI in 2L KRAS-mutant MSS mCRC, enabling more frequent regulatory engagement and potential accelerated pathways.

May 8 (Reuters) - The U.S. Food and Drug Administration has approved Partner Therapeutics' drug for adults with a rare form ...

With Fast Track designation, we believe this can support the acceleration of our Phase 3 program through earlier and more frequent FDA engagement, enabling faster addressing of development questions, ...