Zepbound (Tirzepatide) Receives FDA Approval for Multi-Dose KwikPen

Eli Lilly and Company

Eli Lilly expands Zepbound access with FDA-approved KwikPen multi-dose device. Patients can now choose between KwikPen or single-dose vials at the same price through LillyDirect, with self-pay pricing offering 50% or greater discount compared to other GLP-1 medicines.

U.S. FDA Approves Venclexta and Acalabrutinib Combination for First-Line CLL Treatment

AbbVie

On February 20, 2026, the U.S. FDA approved the combination of Venclexta (venetoclax) and acalabrutinib for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This landmark decision establishes the first and only all-oral, fixed-duration (time-limited) regimen for previously untreated patients, offering a significant alternative to continuous therapy or chemoimmunotherapy

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.

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.

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.

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.

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.

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.

U.S. FDA Approves AKEEGA®, the First Precision Therapy for BRCA2-Mutated Metastatic Prostate Cancer, Slashing Disease Progression Risk by 54%

JohnsonAndJohnson

A major advance in prostate cancer treatment: The FDA has approved AKEEGA® for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This first-of-its-kind precision therapy, combining niraparib and abiraterone, demonstrated a significant 54% reduction in the risk of disease progression or death compared to the standard of care. This milestone offers a personalized, highly effective option for patients with this aggressive genetic mutation.