USFDA

Genentech has announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq and Tecentriq Hybreza for the adjuvant treatment of adults with muscle-invasive bladder cancer (MIBC) who show circulating tumor DNA molecular residual disease (ctDNA MRD) after bladder removal surgery. The approval marks the first FDA-cleared ctDNA-guided therapy approach for this aggressive cancer type.

The U.S. Food and Drug Administration (FDA) has announced a new initiative aimed at accelerating the repurposing of already approved medicines to treat diseases with significant unmet medical needs, including rare disorders, neurodegenerative diseases, metabolic conditions, and substance use disorders.

Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

Cipla Limited and its wholly owned subsidiary Cipla USA Inc., announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation from the United States Food and Drug Administration (USFDA). It is the first AB–rated generic therapeutic equivalent of Ventolin® HFA, marketed by GlaxoSmithKline.

Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otarmeni™ (lunsotogene parvec-cwha), the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program.

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems.

When used alongside a reduced-calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off. Foundayo will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers.