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The U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
The U.S. Food and Drug Administration has approved Basilea Pharmaceutica International Ltd.'s new Zevtera Antibiotic (ceftobiprole medocaril sodium for injection) for three different bacterial infections.
The U.S. Food and Drug Administration granted de novo marketing authorization for Invitae's Common Hereditary Cancers Panel, an in vitro diagnostic test to help detect dozens of cancer types.
The U.S. Food and Drug Administration approved Harm Reduction Therapeutics' RiVive, 3 milligram naloxone hydrochloride nasal spray for over-the-counter or OTC, nonprescription use for the emergency treatment of known or suspected opioid overdose.
The U.S. Food and Drug Administration approved Pfizer Inc's COVID-19 oral antiviral pill Paxlovid for the treatment of mild-to-moderate COVID-19 in adults. Paxlovid is the first oral treatment, and the fourth drug, approved by the agency to treat COVID-19 in adults.
The U.S. Food and Drug Administration announced the supplemental approval of Rexulti (brexpiprazole) oral tablets to treat agitation associated with dementia due to Alzheimer's disease.
The U.S. Food and Drug Administration approved Gamida Cell Ltd.'s Omisirge (omidubicel-onlv) cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation.