Category: Regulatory

News Clinical Data Oncology Regulatory

GSK Secures Japan Orphan Drug Designation for Risvutatug Rezetecan in Small-Cell Lung Cancer

GSK - GlaxoSmithKline

GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data from the ARTEMIS-001 trial, this B7-H3-targeted antibody-drug conjugate aims to transform the prognosis for patients with extensive-stage disease, who currently face a median survival of just 8 months. This marks the sixth major global regulatory designation for risvutatug rezetecan, signaling its critical role in the future of oncology.

Regulatory Approval Autoimmune Diseases News

ICOTYDE FDA Approval: J&J’s First-Line Oral Peptide Breakthrough for Plaque Psoriasis Treatment

JohnsonAndJohnson

ohnson & Johnson has announced FDA approval of ICOTYDE (icotrokinra), the first and only IL-23R targeted oral peptide designed for first-line systemic treatment of moderate-to-severe plaque psoriasis. This groundbreaking approval represents a paradigm shift in dermatology, offering patients unprecedented efficacy with complete skin clearance in over 70% of clinical trial participants.

Regulatory Approval News Oncology

European Commission Grants Approval for AKEEGA®: A New Precision Medicine Milestone for BRCA-Mutated Metastatic Prostate Cancer

JohnsonAndJohnson

Johnson & Johnson secures EC approval for AKEEGA® as the first precision-medicine combo for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer, supported by landmark rPFS data from the AMPLITUDE trial.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

Johnson & Johnson Announces FDA Approval of TECVAYLI® Plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma

JohnsonAndJohnson

Johnson & Johnson announced FDA approval of TECVAYLI plus DARZALEX FASPRO for relapsed/refractory multiple myeloma with unprecedented clinical data demonstrating significant improvements in progression-free survival and overall survival.

Regulatory Healthcare & Pharmaceuticals News

J&J’s Nipocalimab Receives FDA Fast Track Designation for Systemic Lupus Erythematosus

JohnsonAndJohnson

Johnson & Johnson announces FDA Fast Track designation for nipocalimab in systemic lupus erythematosus. The immunoselective therapy demonstrated reduction in lupus disease activity in Phase 2 JASMINE study, offering potential steroid-sparing benefits and accelerated FDA review timeline.

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.