Curated news and analysis on clinical trials, drug approvals, and medical research.
New treatments for rare pediatric neurological conditions show promise, with zorevunersen reducing seizures in Dravet syndrome patients and an SMA therapy under FDA review following stem cell research breakthroughs.
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.
Protagonist Therapeutics reported fourth quarter and full year 2025 financial results, with two NDAs submitted and multiple Phase 3 trials advancing. The company holds $646 million in cash and expects regulatory decisions in 2026.
Altimmune's pemvidutide received FDA Breakthrough Therapy Designation for MASH treatment, with Phase 3 trial initiation planned for 2026. The company raised $75 million in January 2026 to fund development.
Zealand Pharma reported full-year 2025 revenue of DKK 9.2 billion, bolstered by a significant upfront payment from Roche. The company ended the year with DKK 15.1 billion in cash and set 2026 operating expense guidance between DKK 2.72 billion and DKK 3.3 billion.
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.
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.
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.
CSPC Pharmaceutical Group has received approval from China's National Medical Products Administration to begin clinical trials for three drug candidates: a hemophilia A biosimilar, a long-acting pain medication, and an injection designated SYH9089.
Ireland announces Critical Infrastructure Bill to fast-track government-designated projects, while Canada's six-month-old Major Projects Office has yet to accept any of 13 referred projects including Iqaluit's hydroelectric plant.
A nationwide survey reveals 50% of Americans don't know colorectal cancer can be screened at home, as the disease becomes the leading cause of cancer death in adults under 50. Current guidelines recommend screening begin at age 45.
Enlicitide decanoate demonstrated efficacy in reducing LDL cholesterol levels compared to placebo in patients with atherosclerotic cardiovascular disease history or risk, according to phase 3 CORALreef Lipids trial data.
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.
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.
Phase III KEYNOTE-B15 trial demonstrates enfortumab vedotin plus pembrolizumab significantly improves event-free survival and pathologic complete response rates compared with cisplatin-based chemotherapy in muscle-invasive bladder cancer.
Whole genome sequencing, comprehensive genomic profiling, and spatial multiomics are transforming precision medicine from research tools to clinical applications in oncology, rare diseases, and neonatal care, enabling faster diagnoses and personalized treatments.
New research suggests GLP-1 medications like Ozempic and Wegovy could help protect the heart after a heart attack by reopening tiny blood vessels that remain blocked even after major arteries are cleared during emergency treatment.
New research reveals GLP-1 receptor agonists reduce substance use disorders by 14%, lower Parkinson's disease risk after 5-10 years of use, and cut endometrial cancer risk by 66% when combined with progestin therapy.
A large study of over 600,000 U.S. veterans with type 2 diabetes found GLP-1 medications reduced the risk of developing substance use disorders by 14% and cut drug-related deaths by 50% in those with existing addiction.
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.
