The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and credible affordability commitments, while redefining how companies must innovate, scale, and launch therapies in 2025 and beyond.
Approval of Komzifti (ziftomenib) provides a new targeted option for a high-risk patient population and strengthens the Kura Oncology–Kyowa Kirin collaboration, which includes a global development and commercialization strategy.
FDA introduces a new drug approval process, the Plausible Mechanism Pathway, streamlining drug approvals for personalized therapies targeting rare genetic diseases without traditional trials.
Following the removal of George Tidmarsh, HHS and FDA has appointed Richard Pazdur, M.D., director of CDER.
Per the FDA's request, HHS is updating hormone therapy labels, removing misleading warnings to empower women in managing menopause and improving their health options.
The FDA has added six new therapies to its Commissioner’s National Priority Voucher program, bringing the total to 15 products that address major public health needs, including obesity, cancer, sickle cell disease, and drug-resistant tuberculosis.
Johnson & Johnson secures FDA approval for Darzalex Faspro as the first and only treatment for adults with high-risk smoldering multiple myeloma, supported by Phase III Aquila trial data showing a 51% reduction in disease progression or death.
FDA’s approval of Caplyta as an adjunctive treatment to oral antidepressants for major depressive disorder in adults, expands the drug’s use to a fourth indication following positive Phase III trial results.
Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.
There are conflicting reports as to the cause, although it appears to be related to a lawsuit that alleges inappropriate conduct.
Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.
The FDA has approved a new single-injection, once-monthly maintenance regimen for Eli Lilly’s Omvoh (mirikizumab-mrkz), offering adults with moderately to severely active ulcerative colitis a more convenient dosing option that maintains proven efficacy and long-term remission outcomes.
The FDA has updated the label for Merck’s Winrevair (sotatercept-csrk) following results from the Phase III ZENITH trial, confirming the therapy’s ability to reduce the risk of clinical worsening events in adults with pulmonary arterial hypertension.
Lynkuet, a hormone-free therapeutic option for hot flashes associated with menopause, is expected to be available in the United States in November 2025.
GSK's Blenrep gains FDA approval, offering new hope for multiple myeloma patients with improved survival rates and community access.
Sanofi's Tzield gains FDA's expedited review, promising rapid access to innovative treatment for type 1 diabetes and addressing significant medical needs.
FDA approves innovative treatments for lupus nephritis and cardiovascular risk in diabetes, enhancing chronic disease management options for patients.
Amgen and AstraZeneca’s Tezspire (tezepelumab-ekko) gains FDA approval as an add-on maintenance therapy for patients aged 12 and older with inadequately controlled chronic rhinosinusitis with nasal polyps.
Nine medications are on the initial list of program participants.
Regeneron's Libtayo gains FDA approval as the first immunotherapy for high-risk cutaneous squamous cell carcinoma, enhancing patient treatment options.
FDA approves Jascayd, the first new treatment for idiopathic pulmonary fibrosis in over a decade, significantly reducing mortality risk for patients.
Johnson & Johnson's Simponi gains FDA approval for treating pediatric ulcerative colitis, expanding options for young patients with this chronic condition.
Neurizon Therapeutics advances ALS treatment as FDA lifts clinical hold on NUZ-001, paving the way for Phase II and III trials.
Roche's Tecentriq and lurbinectedin combo gains FDA approval, significantly improving outcomes for extensive-stage small cell lung cancer patients.
Jazz Pharmaceuticals announces FDA approval of Zepzelca and Atezolizumab for extensive-stage small cell lung cancer, enhancing treatment options and survival rates.
