A new report released by GlobalData showed that there was a 16 percent decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration during 2019
The U.S. Food and Drug Administration granted “fast track” designation to Moderna Inc.’s experimental coronavirus vaccine, a move that speeds up the regulatory review process.
The U.S. Food and Drug Administration approved AstraZeneca and Merck’s Lynparza (olaparib) in combination with Roche’s Avastin (bevacizumab) for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer has been tested to have either a deleterious or suspected deleterious BRCA mutation and/or genomic instability.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
The U.S. Food and Drug Administration issued Emergency Use Authorization (EUA) Abbott’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.
Rutgers’ RUCDR Infinite Biologics received an amended Emergency Use Authorization from the U.S. Food and Drug Administration for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.
The first treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) who also have a specific genetic mutation was approved by the U.S. Food and Drug Administration.
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.
The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) for the treatment of heart failure in adults with reduced ejection fraction.
Data-focused CRO MMS Holdings Inc. announced that a successful collaboration with Shanghai-based Green Valley Pharmaceutical Co. resulted in gaining U.S. Food and Drug Administration approval of an Investigational New Drug application for the GV-971 international multi-center Phase III clinical study in the treatment of patients with Alzheimer’s disease.
