August 1st 2025
The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein cholesterol management.
FDA Extends Review Period for Bayer’s Elinzanetant for Moderate to Severe Menopausal Symptoms
July 29th 2025The extended review for Elinzanetant is supported by data from the Phase III OASIS 1, 2, and 3 trials, which supported the drug’s efficacy in the treatment of moderate to severe vasomotor symptoms due to menopause.
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
July 22nd 2025The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.
FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir in HIV
July 14th 2025The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed that the doravirine/islatravir combination was non-inferior to both baseline antiretroviral therapy and to bictegravir/emtricitabine/tenofovir alafenamide in treating HIV.
FDA Grants Accelerated Approval to Regeneron’s Lynozyfic for Relapsed or Refractory Multiple Myeloma
July 7th 2025Accelerated approval was based on results from the Phase I/II LINKER-MM1 trial, which showed a 70% objective response rate in patients with relapsed or refractory multiple myeloma treated with Lynozyfic.
FDA Approves Label Updates for BMS' Breyanzi, Abecma in Lymphoma, Myeloma
June 27th 2025Label changes remove Risk Evaluation and Mitigation Strategy programs and eases monitoring requirements, supporting broader access to Bristol Myers Squibb’s CAR T-cell therapies Breyanzi and Abecma for patients with large B cell lymphoma and multiple myeloma.
FDA Approves Incyte’s Monjuvi for Relapsed or Refractory Follicular Lymphoma
June 20th 2025Approval was based on results from the Phase III inMIND trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in patients treated with Monjuvi combined with rituximab and lenalidomide for relapsed or refractory follicular lymphoma.
FDA Approves Gilead’s Yeztugo as First Twice-Yearly Injection for HIV Pre-Exposure Prophylaxis
June 19th 2025Approval of first twice-yearly HIV pre-exposure prophylaxis was based on results from the Phase III PURPOSE 1 and PURPOSE 2 trials, which show that ≥99.9% of patients treated with Yeztugo remained HIV-negative.
Bayer Submits FDA New Drug Application for Low-Dose Macrocyclic Gadolinium Agent for MRI Use
June 19th 2025The investigational MRI contrast agent, gadoquatrane, is designed to deliver effective imaging at a significantly reduced gadolinium dose, supporting safer repeat use in adults and pediatric patients.
FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
June 18th 2025Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.