Suzetrigine, marketed as Journavx, is a first-in-class, oral, non-opioid analgesic, officially approved by the FDA on January 30, 2025 for treating moderate-to-severe acute pain in adults. It fills a long-standing void—being the first new non-opioid pain medication approved in over 20 years.
Avmapki Fakzynja Co-Pack, a co-packaged oral combination of avutometinib capsules and defactinib tablets, received accelerated approval from the U.S. FDA on May 8, 2025 for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have undergone at least one prior systemic therapy
FDA – U.S. Food and Drug Administration (FDA) approved Belzutifan (brand name Welireg, developed by Merck & Co.) for the treatment of locally advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL)
From January to August 2025, the FDA approved 25 novel drugs – nearly one per week – reflecting an unprecedented pace in expanding treatment options across therapeutic areas
Dr. Vinay Prasad, a hematologist-oncologist and outspoken critic of both FDA approval standards and public health policy, was appointed in May 2025 by Commissioner Marty Makary to lead CBER, the FDA division overseeing vaccines, gene therapies, and blood products
U.S. Food and Drug Administration (FDA) granted full approval to Modeyso (generic name: dordaviprone), a groundbreaking therapy for diffuse midline glioma (DMG) — a rare and highly aggressive brain tumor that primarily affects children, adolescents, and young adults. This marks the first time a systemic (body-wide) therapy has been approved for this devastating disease, representing a pivotal advance in neuro-oncology.
