USFDA

AstraZeneca and Daiichi Sankyo have announced that the U.S. Food and Drug Administration (FDA) has approved DATROWAY (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval makes DATROWAY the first TROP2-directed antibody-drug conjugate (ADC) approved in the United States for first-line treatment in this patient population.

In a major breakthrough for liver disease treatment, Gilead Sciences has received accelerated approval from the U.S. FDA for Hepcludex (bulevirtide-gmod), making it the first and only approved therapy for chronic Hepatitis Delta Virus (HDV) infection in the United States.

The U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis (scarring), liver cancer, liver failure, and even death.

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.