Category: Regulatory

Regulatory Approval News Oncology

PADCEV and Keytruda FDA Approval: Breakthrough Perioperative Treatment Cuts Bladder Cancer Death Risk by 50%

pfizer news

The FDA has approved PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as the first perioperative treatment regimen to significantly improve survival in cisplatin-ineligible patients with muscle-invasive bladder cancer. Based on pivotal Phase 3 EV-303 trial data, the combination demonstrated a 60% reduction in recurrence or death risk and a 50% reduction in mortality risk compared to surgery alone.

Regulatory Approval News Oncology

Pfizer’s BRAFTOVI Receives FDA Full Approval for First-Line Metastatic Colorectal Cancer Treatment

pfizer news

Pfizer announced FDA full approval of BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for treating adults with BRAF V600E-mutant metastatic colorectal cancer. The landmark approval is backed by Phase 3 BREAKWATER trial data demonstrating a 51% reduction in mortality risk and 47% reduction in disease progression risk compared to standard chemotherapy.

Weight-loss Drugs Healthcare & Pharmaceuticals News Regulatory Approval

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.

Regulatory Approval News Oncology

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

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.