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On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, …

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma Read More »

EMA has recommended granting a marketing authorisation in the European Union for Kygevvi (doxecitine and doxribtimine) in patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) whose disease started at or before 12 years of age. TK2d is a rare, life-threatening genetic disease that affects fewer than 1 in 1,000,000 people and for which there is no …

First treatment for rare thymidine kinase 2 deficiency Read More »

EMA has recommended granting a conditional marketing authorisation for Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease (GvHD) in adults and in children aged 12 years and older with a body weight of at least 40 kg. The medicine is to be used when other treatment options provide limited clinical benefit, are not suitable, or have …

New medicine to treat chronic graft-versus-host disease Read More »

EMA’s human medicines committee (CHMP) has started a review of Tavneos (avacopan), following emerging information that raises questions regarding the data integrity of the Advocate study, which was the main study supporting the medicine’s marketing authorisation in the European Union.

EMA has recommended extending the therapeutic indication of Zynyz (retifanlimab) to include treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally recurrent. It is used in combination with carboplatin and paclitaxel (chemotherapy medicines).

FDA approved modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize burden on patients, prescribers, and pharmacies while maintaining the safe use of isotretinoin.

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the …

Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency Read More »

On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).