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.
AbbVie’s Qulipta Demonstrates Superiority in Migraine Prevention
June 18th 2025Results from the Phase III TEMPLE trial show that patients administered Qulipta (atogepant) experienced significantly fewer treatment discontinuations due to adverse events compared to topiramate for preventative migraine treatment.
FDA Approves Expanded Indication for AbbVie’s Mavyret in Acute Hepatitis C
June 12th 2025Mavyret marks the first and only direct-acting antiviral approved to treat both acute and chronic hepatitis C virus infections in adults and children aged three years and older, without cirrhosis or with compensated cirrhosis.
Executive Orders and Drug Pricing: Constitutional Limits on the Most Favored Nation Model
June 11th 2025Ron Lanton, Partner, Lanton Law, discusses the constitutional and statutory challenges facing the President’s use of executive orders to implement international drug pricing models such as the Most Favored Nation, highlighting the ongoing debate over separation of powers and congressional authority.
FDA Approves Merck’s Enflonsia to Prevent Respiratory Syncytial Virus
June 10th 2025Approval of Enflonsia was based on data from the Phase IIb/III CLEVER trial, which showed a 60.5% reduction in medically attended lower respiratory infections and an 84.3% reduction in respiratory syncytial virus-related hospitalizations.
Pharmaceutical Industry Faces Legal Uncertainty Over MFN Executive Order
June 10th 2025Ron Lanton, Partner, Lanton Law, outlines how the MFN executive order may face significant legal challenges from the pharmaceutical industry, citing concerns over due process, intellectual property, and regulatory overreach.