You are here: Industry Insights > FDA

News List

FDA grants ARX788 fast track designation for HER2-positive metastatic breast cancer pharmaceutical-business-review
January 07, 2021
Ambrx announced that the US Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based ...
Lupin gets US FDA approval for Sulfamethoxazole and Trimethoprim expresspharma
January 07, 2021
Lupin has received the United States Food and Drug Administration approval for its Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL.
FDA approves Ebanga (Ansuvimab-zykl) for the treatment of Ebola europeanpharmaceuticalreview
January 06, 2021
Ebanga was approved based on its ability to reduce 28-day mortality in patients with confirmed Ebolavirus infection.
US FDA approves Amphastar’s generic drug to treat severe hypoglycemia pharmaceutical-business-review
January 06, 2021
The US Food and Drug Administration (FDA) has approved the first generic drug produced by Amphastar Pharmaceuticals to treat severe hypoglycemia.
V2ACT Therapeutics Announces IND for V2ACT Study for Pancreatic Cancer americanpharmaceuticalreview
January 05, 2021
V2ACT Therapeutics™ has obtained permission from the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application and may proceed with the clinical investigation of V2ACT in a Phase 1/2a trial for the treatment of newly ...
Glenmark gets final nod for Tadalafil Tablets and tentative approvals for Gabapentin Enacarbil ER Tablets and Apremilast Tablets from US FDA expresspharma
January 04, 2021
Glenmark’s current portfolio consists of 167 products authorised for distribution in the US marketplace.
Cara Therapeutics Submits NDA for KORSUVA Injection americanpharmaceuticalreview
December 31, 2020
Cara Therapeutics has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KORSUVA™ Injection (difelikefalin) for the treatment of moderate-to-severe pruritus in hemodialysis patients.
United Therapeutics Receives Orphan Drug Designation for Treprostinil for Idiopathic Pulmonary Fibrosis americanpharmaceuticalreview
December 30, 2020
United Therapeutics announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
Lupin launches Meloxicam Capsules expresspharma
December 29, 2020
Lupin announced the launch of Meloxicam Capsules, 5 mg, and 10 mg, having received an approval from the United States Food and Drug Administration (US FDA).
US FDA approves first generic glucagon injection to treat severe hypoglycaemia expresspharma
December 29, 2020
The FDA granted this approval to Amphastar Pharmaceuticals of Rancho Cucamonga, California.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 367 368 Next page