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FDA Approves Drug to Treat HIV Infection in Newborns

The U.S. Food and Drug Administration (FDA) has approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in babies from birth up to four weeks weighing at least 2 kg, in combination with other antiretroviral agents. Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.

FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma

On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals). FDA also approved two companion diagnostic devices, the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail (Ventana Medical Systems, Inc./Roche Diagnostics), for identifying patients with HER2-positive (IHC3+ or IHC2+/ISH+) gastric, gastroesophageal junction, and …

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FDA Publishes Guidance for Industry: Evaluation of Therapeutic Equivalence

Today, the U.S. Food and Drug Administration published guidance for industry, Evaluation of Therapeutic Equivalence, which revises and finalizes the draft version published in July 2022. This final guidance clarifies the processes by which certain applicants may request therapeutic equivalence (TE) codes and explains FDA’s TE evaluations, including the assignment of TE codes.

FDA Publishes Draft Guidance for Industry, “Determining Whether to Submit an ANDA or 505(b)(2) Application”

U.S. Food and Drug Administration published the draft guidance for industry titled “Determining Whether to Submit an ANDA or 505(b)(2) Application.” This guidance assists applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) described in sections 505(j) and 505(b)(2) is appropriate for the submission of a …

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