A couple of months after posting positive late-stage data for its quadruplet-in-one-pill for quelling HIV, J&J says it’s filed a marketing application with the FDA ahead of a planned marketing campaign.
Symbiomix Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved its lead product Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
The U.S. Food and Drug Administration(FDA) permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence.
The US Food and Drug Administration(FDA) has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer.
The U.S. Food and Drug Administration (FDA) has granted Checkpoint Therapeutics, Inc. (“Checkpoint”) (CKPT)'s Orphan Drug Designation to CK-101 (also known as RX518), the Company’s third-generation epidermal growth-factor receptor (EGFR) inhibitor, for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC).
The US Food and Drug Administration(FDA) has sent a damning warning letter to drug giant Pfizer Inc (NYSE:PFE) after it received “hundreds of complaints” that the anti-allergy EpiPen device misfired “during life-threatening emergencies”.
Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
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