EC approves Daiichi Sankyo's Vanflyta for acute myeloid leukaemia - MSN

Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer

The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression.
DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy.

Merck gets U.K. approval for sotatercept for PAH - MSN

Anocca submits application to EMA for pancreatic cancer trial

Pfizer Secures Approval for Hemophilia Drug Hympavzi in the EU - MSN

FDA Approves Revuforj (revumenib) for R/R Acute Leukemia with KMT2A Translocation

The FDA has approved Revuforj (revumenib), a menin inhibitor, for relapsed or refractory acute leukemia with KMT2A translocation in adults and pediatric patients.
The approval was based on the AUGMENT-101 trial, which demonstrated strong results in treating patients with this challenging form of leukemia.

FDA Approves Syndax's Revuforj, a First-in-Class Menin Inhibitor for Acute Leukemia

The FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for adults and children with relapsed or refractory acute leukemia with KMT2A rearrangement.
Revuforj, a menin inhibitor, showed a complete remission or complete remission with partial hematologic recovery in 21.2% of study participants, with a median response duration of 6.4 months.

Sandoz's Aflibercept Biosimilar Afqlir Gains European Commission Approval

Sandoz has received European Commission (EC) approval for Afqlir, an aflibercept biosimilar, indicated for retinal diseases including neovascular age-related macular degeneration (nAMD).
Afqlir, biosimilar to Eylea, is expected to launch in Q4 2025, offering a more affordable treatment option for vision loss related to nAMD, macular oedema, diabetic macular oedema and myopic choroidal neovascularisation.

Aflibercept Biosimilars Gain Momentum in Europe with Multiple Approvals and Positive Opinions

The European Medicines Agency's CHMP recommended Amgen's Pavblu and Skojoy, aflibercept biosimilars, for approval in January 2025, expanding treatment options for retinal diseases.
Sandoz's Afqlir (aflibercept) received marketing authorization from the European Commission, offering an affordable alternative for conditions like neovascular AMD, expected to launch in Q4 2025.

European Commission Approves Sandoz's Aflibercept Biosimilar, Afqlir, for Retinal Diseases

The European Commission has granted marketing authorization to Sandoz Group's Afqlir (aflibercept) biosimilar, a 2 mg vial kit and pre-filled syringe for intravitreal injection.
Afqlir is approved for treating retinal diseases, including neovascular age-related macular degeneration (nAMD), offering a more affordable alternative to the reference aflibercept (Eylea).

AstraZeneca gets FDA approval for PNH drug Voydeya - MSN