New Drug Approvals Archives

FDA Grants Full Approval of Deciphera Pharmaceuticals’ Qinlock for Treatment of Fourth-Line Gastrointestinal Stromal Tumor

Approvals, Breakthrough Therapy Designation, Clinical Studies, Fast Track Designation, FDA, FDA Oncology Center of Excellence, FDA/Regulatory, Gastrointestinal Stromal Tumors, Kinase Inhibitors, New Drug Approvals

The U.S. Food and Drug Administration approved Deciphera Pharmaceuticals Inc.’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

May 15, 2020/by Business Wire

U.S. FDA Approves Dr. Reddy’s Laboratories’ Elyxyb

Acute Migraine, Approvals, FDA, FDA/Regulatory, New Drug Application (NDA), New Drug Approvals

Dr. Reddy’s Laboratories Ltd. received approval for Elyxyb (celecoxib oral solution 25 mg/mL) from the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults.

May 6, 2020/by Andrew Humphreys

Bristol Myers Squibb’s Ozanimod Wins FDA Approval for Relapsing Multiple Sclerosis

Acquisitions, Approvals, Business, FDA, FDA/Regulatory, New Drug Approvals, Potential Blockbusters, Relapsing Multiple Sclerosis (RMS)

Bristol Myers Squibb’s Zeposia (ozanimod) won approval from the U.S. Food and Drug Administration as a new treatment for a type of multiple sclerosis.

March 26, 2020/by BioSpace

The FDA Is Approving Drugs Faster, But That May Not Be A Good Thing

Approvals, FDA, FDA/Regulatory, JAMA Network, New Drug Approvals, Prescription Drug User-Fee Act (PDUFA), SSRN, Studies, The Wall Street Journal

In a second research report published this year so far, investigators found that the U.S. Food and Drug Administration (FDA) is approving drugs faster than ever.

January 30, 2020/by BioSpace

FDA approval may not be as rigorous as it once was

Autoimmune Diseases, Biologics, Clinical Trials, Drug Prices, FDA, FDA/Regulatory, Medications, New Drug Approvals

Changes in U.S. Food and Drug Administration procedures meant to speed approvals for medications may have resulted in less exacting standards, a new analysis suggests.

January 14, 2020/by Reuters Health