Aug 13, 2018
FDA Accepts New Drug Application (NDA) to review Midazolam Nasal Spray, an investigational product for the acute treatment of seizure clusters
Aug 10, 2018
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
Aug 08, 2018
FDA approves treatment for two rare types of non-Hodgkin lymphoma
Jul 30, 2018
FDA approves first treatment for rare adrenal tumors
Jul 18, 2018
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
Jul 13, 2018
FDA approves the first drug with an indication for treatment of smallpox
Jun 29, 2018
Enzychem Lifesciences' Growth Continues in US, Adds Jeff Clark as New Chief Licensing Officer
Jun 12, 2018
REGENXBIO Receives FDA Fast Track Designation for RGX-111 Gene Therapy for the Treatment of Mucopolysaccharidosis Type I
May 29, 2018
TrioxBio Announces Fast Track Designation Granted by U.S. FDA to Raviten® for the Treatment of Intradialytic Hypotension
May 21, 2018
Harmony Biosciences Receives Breakthrough Therapy And Fast Track Designations For Pitolisant
May 08, 2018
FDA Grants Fast Track Designation to Debiopharm International's Debio 1347 for the Treatment of Patients With Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration
May 02, 2018
REGENXBIO Receives FDA Fast Track Designation for RGX-121 Gene Therapy for the Treatment of Mucopolysaccharidosis Type II
Apr 25, 2018
FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D
Apr 24, 2018
Enzychem Lifesciences' Fast Track Designation for chemo-radiation induced oral mucositis had been granted by the FDA
Apr 17, 2018
FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
Apr 09, 2018
Stealth BioTherapeutics Granted Orphan Drug Designation for Elamipretide for Treatment of Barth Syndrome
Apr 04, 2018
Proteostasis Therapeutics Receives FDA Fast Track Designation for Triple Combination Program in Patients with Cystic Fibrosis
Mar 29, 2018
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
Mar 19, 2018
FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease
Mar 09, 2018
AmnioFix® Injectable Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the FDA for the Treatment of Osteoarthritis of the Knee