Category: Regulatory

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

FDA Approves Monthly Dosing for J&J’s Rybrevant Faspro, Marking a New Era in Lung Cancer Treatment

JohnsonAndJohnson

FDA approves a new simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in combination with LAZCLUZE (lazertinib) for first-line treatment of EGFR-mutated advanced non-small cell lung cancer. The approval allows patients to transition to monthly injections as early as Week 5, significantly reducing clinic visits while maintaining consistent efficacy with the previously approved bi-weekly schedule. PALOMA-2 trial data demonstrated high objective response rates and a fivefold reduction in administration-related reactions compared to intravenous delivery.

Regulatory Approval Autoimmune Diseases News

Amgen Wins EU Approval for UPLIZNA in Rare Muscle-Weakening Disease, Opening New Front in Autoimmune Battle

amgen

The European Commission has granted approval for Amgen’s UPLIZNA® (inebilizumab) as an add-on treatment for adults with generalized myasthenia gravis making it the first and only CD19-targeted therapy authorized in Europe for this rare, debilitating autoimmune muscle disease. The approval is backed by pivotal Phase 3 data from the landmark MINT trial.

News Healthcare & Pharmaceuticals Regulatory

Pfizer’s HYMPAVZI Receives FDA Priority Review to Expand Treatment to Children and Patients with Hemophilia A or B Without Inhibitors

pfizer news

Pfizer has reached a major regulatory milestone with the FDA granting Priority Review for HYMPAVZI™ (marstacimab) to include children as young as six and patients with hemophilia inhibitors. If approved, HYMPAVZI would become the first non-factor prophylactic treatment for children aged 6–11 with hemophilia B, offering a simplified, once-weekly injection that addresses a massive unmet medical need in the rare disease community.

News Regulatory Approval

FDA Approves First-Ever Weight-Loss Pill: Novo Nordisk’s Wegovy Pill to Launch in January

novo nordisk

The FDA has officially approved the first-ever oral version of Wegovy, a once-daily tablet from Novo Nordisk. With clinical trials showing a 16.6% average weight loss, this landmark approval offers a needle-free alternative for obesity management and cardiovascular protection starting in January 2026.

Regulatory Approval Healthcare & Pharmaceuticals News

FDA Grants Accelerated Approval to Roche’s One-Minute Lymphoma Injection, Lunsumio VELO™

Roche

The FDA has granted accelerated approval to Roche’s Lunsumio VELO™, a revolutionary subcutaneous formulation for adult patients with relapsed or refractory follicular lymphoma. By reducing administration time from several hours to just one minute, this CD20xCD3 bispecific antibody offers a more flexible, outpatient-friendly treatment option. Supported by a 75% objective response rate in heavily pre-treated patients, Lunsumio VELO marks a major shift toward patient-centered oncology care in 2025.

Regulatory Healthcare & Pharmaceuticals News Weight-loss Drugs

Novo Nordisk Seeks FDA Approval for Powerful New Combination Obesity Drug, CagriSema, Following Strong Phase 3 Data

novo nordisk

Novo Nordisk has officially submitted a New Drug Application to the FDA for CagriSema, a first-of-its-class once-weekly injection for chronic weight management. Combining semaglutide with a novel amylin analogue, clinical data from the REDEFINE program shows the treatment can achieve over 20% weight loss in adults with obesity.

Regulatory Approval Healthcare & Pharmaceuticals News

Johnson & Johnson Secures FDA Approval for TRUFILL n-BCA to Treat Chronic Subdural Hematoma

JohnsonAndJohnson

Johnson & Johnson MedTech has secured FDA approval for an expanded indication of the TRUFILL n-BCA Liquid Embolic System. This new approval allows for the treatment of chronic subdural hematoma (cSDH) via middle meningeal artery (MMA) embolization, offering a minimally invasive solution to significantly reduce the high recurrence rates associated with traditional surgery.

Regulatory Approval Healthcare & Pharmaceuticals News

FDA Approves GSK’s Exdensur (depemokimab), the First Twice-Yearly Biologic for Severe Asthma

GSK - GlaxoSmithKline

The U.S. FDA has approved GSK’s Exdensur (depemokimab), a revolutionary ultra-long-acting biologic for severe eosinophilic asthma. As the first treatment of its kind to require only two doses per year, Exdensur promises to improve patient adherence and significantly reduce the frequency of life-threatening asthma attacks.