February 19th 2025
Former leaders of the CDC, FDA, and other agencies condemned the layoffs.
February 18th 2025
FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections
February 11th 2025Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited treatment options.
FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease
February 7th 2025Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease.
FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema
February 4th 2025Roche’s Susvimo, a refillable eye implant for diabetic macular edema, provides continuous delivery of ranibizumab, showing sustained vision improvements with fewer treatments than standard eye injections.
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
January 24th 2025Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken 14 days apart can deliver significant clinical benefits in patients with spinal muscular atrophy.
FDA Grants 510(k) Clearance to Roche’s Cobas Liat Molecular Test for Sexually Transmitted Infections
January 22nd 2025The cobas liat test aims to improve patient outcomes by offering rapid, accurate results in decentralized and community-based settings for patients at risk for chlamydia, gonorrhea, and Mycoplasma genitalium.
FDA Approves Amgen’s Lumakras Plus Vectibix for KRAS G12C-Mutated Metastatic Colorectal Cancer
January 20th 2025Approval is based on data from the Phase III CodeBreaK 300 trial, which demonstrated that treatment with Lumakras and Vectibix significantly improved progression-free survival in patients with KRAS G12C-mutated metastatic colorectal cancer.
FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma
January 17th 2025Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.