FDA Fast Track

Karyopharm Therapeutics Inc (NASDAQ: KPTI) shares are trading higher after the FDA granted Fast Track Designation to the development program of selinexor for myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis....

The FDA has granted Fast Track designation for SAB Biotherapeutics' (NASDAQ: SABS) SAB-176, an investigational therapeutic for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains. What Happened: SAB-176 is produced...

The FDA has granted Fast Track designation to Veru Inc's (NASDAQ: VERU) sabizabulin, oral cytoskeleton disruptor, to combat COVID-19 infection and the cytokine storm responsible for Acute Respiratory Distress Syndrome (ARDS) and death.  Sabizabulin disrupts microtubule...

The FDA has granted Fast Track Designation to Calliditas Therapeutics AB's (NASDAQ: CALT) lead NOX inhibitor candidate setanaxib for primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe. In the Phase 2...

The FDA granted Fast Track designation Moderna Inc's (NASDAQ: MRNA) mRNA-1345, its investigational single-dose mRNA vaccine against the respiratory syncytial virus (RSV) in adults older than 60 years of age. The respiratory syncytial virus is a common respiratory virus that...

The FDA has granted Fast Track designation to Alkermes plc's (NASDAQ: ALKS) nemvaleukin alfa (nemvaleukin) for mucosal melanoma. Nemvaleukin is an investigational engineered interleukin-2 (IL-2) variant immunotherapy. Earlier this year, the FDA also granted orphan drug...

The FDA has granted Fast Track Designation to Catalyst Biosciences Inc's (NASDAQ: CBIO) Marzeptacog alfa (activated), MarzAA, the Company's subcutaneously administered next-generation engineered coagulation Factor VIIa (FVIIa) for episodic bleeding in subjects with...

The FDA has granted Fast Track designation to Applied Therapeutics Inc's (NASDAQ: APLT) AT-007 to treat Galactosemia, a rare metabolic disease. AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic...

The FDA has granted Fast Track Designation for VBI Vaccines Inc's (NASDAQ: VBIV) VBI-1901, its cancer vaccine immunotherapeutic candidate to treat recurrent glioblastoma (GBM) patients with first tumor recurrence. The company also announced the most recent tumor response...

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...