FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma
On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
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 First Drug for Warm Autoimmune Hemolytic Anemia
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.
MSD-Moderna Phase III readout backs personalised mRNA neoantigen combination adjuvant therapy for melanoma
First combination regimen to demonstrate significant reduction in recurrence risk in completely resected stage IIB-IV melanoma compared to Keytruda alone as adjuvant treatment.
EC approves Acadia’s trofinetide as first EU Rett syndrome 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.
Genentech licenses Hanmi’s UCN2 obesity candidate in $2.3bn deal
Potential first-in-class treatment HM17321 offers a non-incretin mechanism of action and differentiated profile from existing GLP-1-based treatments for obesity.
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 …
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 New Product-Specific Guidances to Facilitate Generic Drug Development
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).