Jun 19, 2020
Plakous Therapeutics Receives Rare Pediatric Disease and Orphan Drug Designations for Protego-PD(TM) for the Prevention of Necrotizing Enterocolitis
Jun 03, 2020
Clarity Pharmaceuticals Announces that the US FDA Grants Rare Pediatric Disease Designation to 67Cu-SARTATE(TM) for the Treatment of Neuroblastoma
May 26, 2020
FDA Approves Only Drug in U.S. to Treat Severe Malaria
May 15, 2020
FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors
May 06, 2020
FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer
Apr 22, 2020
FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments
Apr 17, 2020
FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts
Apr 10, 2020
FDA Approves First Therapy for Children with Debilitating and Disfiguring Rare Disease
Mar 31, 2020
MEI Pharma Announces Fast Track Designation Granted by U.S. FDA for ME-401 For the Treatment of Adult Patients with Relapsed or Refractory Follicular Lymphoma
Mar 31, 2020
Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19
Mar 19, 2020
Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments
Mar 03, 2020
FDA Grants Rare Pediatric Disease Designation to Stealth BioTherapeutics for Elamipretide for the Treatment of Barth Syndrome
Feb 20, 2020
BioMarin's Biologics License Application for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA with Review Action Date of August 21, 2020
Feb 19, 2020
Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain
Jan 23, 2020
FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer
Jan 21, 2020
FDA approves first treatment for thyroid eye disease
Dec 19, 2019
First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response
Dec 12, 2019
FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation
Dec 03, 2019
Health Canada Grants Priority Review Status for Heron Therapeutics' New Drug Submission for HTX-011 for Management of Postoperative Pain
Nov 26, 2019
How FDA and Oncology Industry are Making Joint Efforts to Utilize Accelerated Approval Pathways for Cancer Drugs