Regulatory Approval Healthcare & Pharmaceuticals Rare Diseases

U.S. FDA Approves KYGEVVI, the First and Only Treatment for Ultra-Rare Mitochondrial Disease TK2d

UCB News

The U.S. FDA granted approval to KYGEVVI for treating adults and children with Thymidine Kinase 2 Deficiency (TK2d), an ultra-rare, life-threatening mitochondrial disease. Developed by UCB, KYGEVVI is the first and only approved therapy for TK2d, demonstrating a profound 86% reduction in the risk of death and significant improvement in motor function for patients with early-onset disease.

Clinical Trials Healthcare & Pharmaceuticals News

Roche Announces Positive Phase III ALLEGORY Study Results for Gazyva®/Gazyvaro® in Systemic Lupus Erythematosus

Roche

Roche’s Phase III ALLEGORY study for Gazyva® (obinutuzumab) in systemic lupus erythematosus (SLE) met its primary and all key secondary endpoints. These “unprecedented” results demonstrate Gazyva’s potential to effectively control disease activity and may delay or prevent further organ damage in people with SLE.

Business Healthcare & Pharmaceuticals News

Eli Lilly to Invest $3 Billion in New Netherlands Facility to Boost Oral Medicine Production

Eli Lilly and Company

Eli Lilly has announced a $3 billion investment to build a new, state-of-the-art manufacturing facility in Katwijk, Netherlands. Located in the Leiden Bio Science Park, the advanced plant will significantly expand the company’s capacity for its growing portfolio of oral medicines, including the oral GLP-1 drug orforglipron.

Regulatory Autoimmune Diseases News

J&J Seeks U.S. FDA Approval to Expand STELARA® Use for Pediatric Ulcerative Colitis

JohnsonAndJohnson

Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for STELARA® (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis. The filing is supported by data from the Phase 3 UNIFI Jr clinical trial, aiming to address the significant unmet needs for this pediatric patient population.

Business Healthcare & Pharmaceuticals News

AbbVie Q3 Revenue Jumps 9.1% on Immunology Strength; Company Lifts 2025 EPS Guidance

AbbVie

AbbVie announced third-quarter 2025 net revenues of $15.776 billion, a 9.1% increase, fueled by strong growth from its immunology drugs Skyrizi and Rinvoq. GAAP diluted EPS was $0.10, impacted by IPR&D expenses, while adjusted diluted EPS was $1.86. Following the strong quarter, AbbVie raised its full-year 2025 adjusted diluted EPS guidance to $10.61 – $10.65.

Business Healthcare & Pharmaceuticals News

Gilead Announces 2025 Q3 Results; Lifts EPS Guidance as Strong HIV Sales and Other Revenue Drive

Gilead

Gilead Sciences (GILD) reported strong Q3 2025 financial results, with total revenues of $7.8 billion and non-GAAP diluted EPS jumping 22% to $2.47. The performance was driven by a 4% rise in its core business (excluding Veklury), led by its HIV franchise and $3.7 billion in Biktarvy sales. Despite a decline in Veklury and Cell Therapy revenue, the company raised its full-year 2025 diluted EPS guidance.

Business Healthcare & Pharmaceuticals News

Eli Lilly’s Q3 2025 Results Soar: Revenue Jumps 54% on Blockbuster Demand for GLP-1 Therapies; Full-Year Guidance Raised

Eli Lilly and Company

Eli Lilly reported blockbuster Q3 2025 earnings, with revenue hitting $17.6 billion on 54% year-over-year growth. The financial success was overwhelmingly driven by its incretin portfolio, particularly the high-demand GLP-1 drugs Mounjaro and Zepbound, which saw their sales soar. Following the strong performance and R&D momentum including positive Phase 3 data for the oral obesity drug orforglipron Lilly significantly raised its full-year 2025 revenue and EPS guidance.

Artificial Intelligence Business Healthcare & Pharmaceuticals News Technology

Eli Lilly Partners with NVIDIA to Build Pharma’s Most Powerful AI Supercomputer

Eli Lilly and Company

Eli Lilly is building the pharmaceutical industry’s most powerful supercomputer in collaboration with NVIDIA to create an “AI factory.” This massive system, featuring over 1,000 NVIDIA DGX B300 GPUs, will leverage decades of data to train specialized AI models, dramatically accelerating drug discovery and development while running on 100% renewable electricity.

Regulatory Approval Autoimmune Diseases News Regulatory

U.S. FDA Approves Lilly’s Omvoh (mirikizumab-mrkz) as a Single-Injection Monthly Maintenance Dose for Ulcerative Colitis

Eli Lilly and Company

Eli Lilly has received FDA approval for a new single-injection maintenance dose of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis. This approval simplifies the treatment regimen from two monthly injections down to just one, offering the same proven efficacy in a more convenient format. The new 200 mg/2 mL prefilled pens and syringes are expected to be available in the U.S. in early 2026.