Adderall Shortage Drives Shift to Alternative ADHD Medications in Children
January 29th 2025Prescription data between 2017 and 2023 revealed that while Adderall prescription fills decreased following the shortage, many children transitioned to alternative stimulants for attention-deficit/hyperactivity disorder.
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.
Novel GLP-1 Receptor Agonist Demonstrates Promising Results Treating Patients with Obesity
January 21st 2025Data from a Phase Ia single ascending dose study found that ASC30 demonstrated dose-proportional pharmacokinetics, a half-life of up to 60 hours, and superior pharmacokinetic properties compared to other oral GLP-1 receptor agonists.
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.