According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for ...

Cabozantinib, an oral tyrosine kinase inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with previously treated advanced neuroendocrine ...

The U.S. Food and Drug Administration recently authorized the marketing of 20 nicotine pouch products under the Zyn brand, including flavors like Wintergreen and the "unflavored" Chill. That ...

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase ® (tenecteplase), a thrombolytic or clot-dissolving agent, for the ...

Philippines – The government is seeking to get approval from the Food and Drug Administration (FDA) for commercial use of African swine fever vaccines by April. The Department of Agriculture (DA ...

The FDA approved GSK’s drug for a common type of urinary tract infection in women and adolescent girls. REUTERS/Chris J. Ratcliffe/File Photo GSK is banking on new drugs in its infectious ...

The company states: “Novartis (NVS) announced that oral Fabhalta, iptacopan, has received U.S. Food and Drug Administration approval for the treatment of adults with C3 glomerulopathy ...

Theratechnologies (THTX) announced that the FDA has approved the Company’s supplemental Biologics License Application, or sBLA, for the F8 formulation of tesamorelin for injection. The Company ...

The FDA is expected to decide on treatments for ... The Company is seeking approval for acute treatment of migraine with or without aura.

President Donald Trump's choice to lead the Food and Drug Administration (FDA), Johns Hopkins School of Medicine professor Dr. Marty Makary, was confirmed in the Senate on Tuesday. His ...

The FDA last week approved (PDF) Neurotech’s cell therapy implant revakinagene taroretcel to treat the vision-robbing neurodegenerative disease macular telangiectasia (MacTel) type 2.

He will take over leadership of the agency as the FDA has been targeted by sweeping cuts by Elon Musk’s so-called Department of Government Efficiency. Makary said during his confirmation hearing ...