Aug 13, 2020
ANTI-PD-1/CTLA-4 Bi-specific Antibody (AK104) of Akeso Granted FDA Fast Track Designation for Recurrent and Metastatic Cervical Cancer
Jun 10, 2020
F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections
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 15, 2020
FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer
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 18, 2020
Biohaven's Verdiperstat Receives Fast Track Designation For The Treatment Of Multiple System Atrophy
Mar 12, 2020
Agenus Receives Fast Track Designation for Balstilimab & Zalifrelimab in Advanced Cervical Cancer
Feb 19, 2020
Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain
Feb 13, 2020
FDA Grants Soligenix "Fast Track" Designation for RiVax® in the Prevention of Ricin Poisoning
Jan 28, 2020
FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
Jan 21, 2020
FDA approves first treatment for thyroid eye disease
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 25, 2019
FDA approves novel treatment to target abnormality in sickle cell disease
Nov 21, 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia
Nov 20, 2019
FDA approves first treatment for inherited rare disease