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Mar 05, 2026
The global biosimilar market is experiencing robust growth, valued at USD 36.79 billion in 2024 and projected to reach USD 282.3 billion by 2035 at a CAGR of 20.35%, driven by patent expirations, cost pressures, and expanding access to biologic therapies.
Mar 05, 2026
The FDA has placed a partial clinical hold on PepGen's Phase 2 FREEDOM2-DM1 trial for myotonic dystrophy type 1, citing questions about preclinical pharmacology and toxicology studies. The company is submitting additional analyses to address the FDA's concerns.
Mar 05, 2026
Medicus Pharma reported Phase 2 SKNJCT-003 topline data showing 73% clinical clearance and 40% histological clearance at Day 57 in the 200μg cohort. Separately, the FDA cleared the company to begin a Phase 2b dose optimization study for Teverelix in advanced prostate cancer.
Mar 05, 2026
Affinia Therapeutics has received FDA fast track designation and EMA orphan drug designation for AFTX-201, an investigational gene therapy for BAG3-associated dilated cardiomyopathy, a rare genetic heart disease affecting over 70,000 patients.
Mar 05, 2026
The cardiovascular biologics market is projected to reach $4.23 billion by 2033, while the cell therapy market is expected to reach $5.38 billion by 2032, driven by RNA-based therapies and regulatory approvals.
Mar 05, 2026
The large molecule drug substance CDMO market is expected to grow at approximately 9% CAGR through 2031, driven by rising demand for biologics and biosimilars, streamlined regulatory approval pathways, and increasing FDA and EMA approvals for biologic therapies.
Mar 05, 2026
Finerenone met its primary endpoint in reducing albuminuria in type 1 diabetic kidney disease, marking the first successful drug trial in 30 years for this population. Separately, SGLT2 inhibitors showed superior kidney protection compared to GLP-1 medications in type 2 diabetes patients.
Mar 05, 2026
Sixteen pharmaceutical companies have voluntarily agreed to Most Favored Nation pricing covering 70% of Medicare drug spending, while industry leaders warn of China's growing competitiveness in drug development and clinical trials.
Mar 05, 2026
FDA approved pembrolizumab with paclitaxel, with or without bevacizumab, for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with PD-L1 CPS ≥1, based on KEYNOTE-B96 trial results.
Mar 03, 2026
Acurx Pharmaceuticals will discuss full year and fourth quarter 2025 financial results on March 13, 2026, and provide updates on ibezapolstat, its lead antibiotic candidate preparing for international Phase 3 trials for C. difficile infection.
Mar 05, 2026
The FDA granted Breakthrough Therapy designation to NGN-401, Neurogene's gene therapy for Rett syndrome, based on interim data showing durable functional improvements. The company expects to complete pivotal trial dosing in Q2 2026.
Mar 05, 2026
AbbVie has successfully transitioned from Humira dependence to growth driven by Skyrizi and Rinvoq, while maintaining a 54-year dividend increase streak and expanding its pipeline to roughly 90 programs through strategic acquisitions.
Mar 04, 2026
Ocular Therapeutix's Axpaxli outperformed low-dose Eylea in a Phase 3 trial for wet AMD, while Oculis Holding reported narrowed Q4 losses and expects Phase 3 trial readouts for OCS-01 in Q2 2026.
Mar 04, 2026
Citius Pharmaceuticals reported $3.9 million in first revenue from LYMPHIR's December 2025 launch for cutaneous T-cell lymphoma, while subsidiary Citius Oncology announced positive Phase 1 data showing 86% response rate when LYMPHIR was administered prior to CAR-T therapy in high-risk lymphoma patients.
Mar 04, 2026
Novo Nordisk filed a patent infringement lawsuit against Hims & Hers over compounded versions of Wegovy. The legal action follows the telehealth company's announcement of a $49 oral pill, which was withdrawn after FDA warnings.
Mar 04, 2026
A computational histology artificial intelligence platform can predict which of two chemotherapy regimens is more effective for individual pancreatic cancer patients, according to a study published in the Journal of Clinical Oncology.
Mar 04, 2026
Roche signed an agreement to invest $478 million in Korea clinical trials over five years, marking the largest foreign pharmaceutical investment. Korean companies are also securing pre-approval licensing deals globally, demonstrating growing competitiveness.
Mar 04, 2026
The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.
Mar 04, 2026
The alopecia areata treatment market is projected to grow significantly through 2036, driven by rising prevalence and the anticipated launch of emerging therapies including JAK inhibitors and novel drug classes targeting immune pathways.
Mar 04, 2026
The 2026 ASCO GU Symposium featured significant trial results in renal cell carcinoma, urothelial carcinoma, and prostate cancer, including data from LITESPARK-022, KEYNOTE-B15, SunRISE-2, and PEACE-3 studies.
