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.
The U.S. Food and Drug Administration (FDA) has approved Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.
First combination regimen to demonstrate significant reduction in recurrence risk in completely resected stage IIB-IV melanoma compared to Keytruda alone as adjuvant treatment.
European approval of the IGF-1-derived small molecule analogue offers a new option for patients aged five and over with the rare neurodevelopmental disorder.
Potential first-in-class treatment HM17321 offers a non-incretin mechanism of action and differentiated profile from existing GLP-1-based treatments for obesity.
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 …
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.
The U.S. Food and Drug Administration published a new batch of draft product-specific guidances (PSGs) for developing generic drugs and generating evidence for abbreviated new drug applications (ANDAs).
The U.S. Food and Drug Administration (FDA) has approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification (bone formation outside the skeleton) and reduce clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). Pasatru is the second drug approved for patients with this very rare disease.
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 …
