Sun Pharmaceutical Industries Ltd.’s drug shipments from its Gujarat plant could be refused entry in its key U.S. market after the drug regulator slapped an import alert on the facility, the drugmaker said on Thursday.
Tag Archive for: U.S. Food and Drug Administration (FDA)
E-cigarette maker Juul Labs on Tuesday said it has reached settlements with about 10,000 plaintiffs covering more than 5,000 cases in California
Pfizer Inc. said on Wednesday the U.S. Food and Drug Administration will review its respiratory syncytial virus (RSV) vaccine candidate on priority.
Contract drugmaker Emergent Biosolutions said on Tuesday its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator.
Pfizer Inc. and its German partner BioNTech SE said on Monday they have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization of their Omicron-adapted COVID-19 vaccine booster for children aged 6 months through 4 years.
Ionis Pharmaceuticals Inc. announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for review of tofersen, an investigational medicine for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). SOD1-ALS is a progressive and uniformly fatal disease that affects fewer than 1,000 people across Europe.
As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody Tecentriq (atezolizumab) for a specific type of previously untreated metastatic bladder cancer.
The FDA has accepted Roche and Sarepta’s Biologic License Application for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec), an investigational gene therapy for Duchenne muscular dystrophy (DMD).
Kintara Therapeutics Inc., a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC).
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
