Fast Track Designation

The FDA has granted Fast Track designation to GSK plc's (NYSE: GSK) investigational vaccine for Neisseria gonorrhea. The vaccine is currently in an ongoing Phase 2 trial. The trial aims to demonstrate proof of concept by assessing the vaccine's efficacy in healthy adults...

Awakn Life Sciences Corp. (OTCQB: AWKNF), a biotech company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), has been granted an Innovation Passport for its proprietary Ketamine-Assisted Therapy (KAT) to treat severe AUD. The passport...

Ketamine products manufacturer PharmaTher Holdings Ltd. (OTCQB: PHRRF) had lots happening this past week. Here are the company's top three news items. FDA’s Orphan Drug Status To Ketamine For Rett Syndrome The FDA granted an orphan drug designation to the company’s proprietary...

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PDS Biotechnology's (NASDAQ: PDSB) lead drug candidate PDS0101 in combination with KEYTRUDA (pembrolizumab) for the treatment of patients with recurrent or metastatic HPV16-positive head and neck cancer....

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Midatech Pharma PLC's (NASDAQ: MTP) lead drug candidate MTX110 for the treatment of patients with recurrent glioblastoma (rGBM). The company is planning to begin recruitment in the phase 1 study evaluating MTX110...

The FDA has granted Fast Track designation to Sutro Biopharma Inc's (NASDAQ: STRO) STRO-002 for ovarian cancer. The designation covers platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients who have received one to three prior lines of...

The FDA has granted Fast Track designation to Edgewise Therapeutics Inc's (NASDAQ: EWTX) EDG-5506 for Becker Muscular Dystrophy (BMD). EDG-5506, a selective, small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers in DMD and BMD....

The FDA has granted Fast Track Designation to Palisade Bio Inc's (NASDAQ: PALI) investigational drug LB1148, which has the potential to be the first oral treatment to reduce adhesions following abdominal or pelvic surgery. LB1148 was previously granted Fast Track...

The FDA has granted Fast Track designation to Fulcrum Therapeutics Inc's (NASDAQ: FULC) losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy (FSHD). Fulcrum is on track to report full data from the ReDUX4 Phase 2b trial at the virtual FSHD...

The FDA has granted Fast Track designation to Cerecor Inc's (NASDAQ: CERC) CERC-002 to treat hospitalized patients with COVID-19. CERC-002 is a first-in-class fully human monoclonal antibody targeting LIGHT (tumor necrosis factor superfamily member 14, TNFSF14). Fast...

The FDA has granted Fast Track designation to Akari Therapeutics Plc's (NASDAQ: AKTX) nomacopan to treat patients with moderate and severe Bullous Pemphigoid (BP). Nomacopan has also been granted orphan drug designation for nomacopan to treat BP by the FDA and the...