Drug Approval | February 19, 2022
Amneal expands injectables portfolio with four new products
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
The agreement also had a permanent safeguard mechanism which can be resorted to in a situation of sudden surge in imports.
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
AptarGroup acquired Voluntis and 80% of Weihai Hengyu Medical Products in 2021.
More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline
With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation
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