Curated news and analysis on clinical trials, drug approvals, and medical research.
Analysts project AI in clinical trials will represent an $8 billion business segment by 2030, generating up to $110 billion per year in value to pharma. Multiple companies unveiled AI-powered platforms at SCOPE 2026 in Orlando.
The FDA placed clinical holds on Regenxbio's RGX-111 and RGX-121 gene therapies following a tumor case in an MPS I patient. The company's stock fell nearly 18% on the news.
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
Ultragenyx Pharmaceutical faces federal securities class action lawsuits following the failure of Phase 3 Orbit and Cosmic studies for setrusumab in Osteogenesis Imperfecta, with stock falling over 42% after December 2025 results announcement.
Praxis Precision Medicines has submitted new drug applications for ulixacaltamide in essential tremor and relutrigine in rare epilepsies, both granted Breakthrough Therapy Designation. The company reported $926 million in cash as of December 31, 2025.
Drug Hunter's most-accessed resources, reviews, and case studies in 2025 reflected key trends in drug discovery, including the rise of oral macrocycles, advances in new modalities, and the shift from biologics to small molecules in immunology.
Artificial intelligence emerged as the dominant topic in clinical research during 2025, with applications spanning operational efficiency, drug discovery, and patient recruitment, though no AI-discovered drug has yet achieved FDA marketing approval.
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
A nationwide study of US veterans with type 2 diabetes found semaglutide initiation more than doubled the risk of nonarteritic anterior ischemic optic neuropathy compared to SGLT2 inhibitors, though absolute risk remained low at 0.29%.
Takeda announced positive Phase 3 results for zasocitinib in adults with moderate-to-severe plaque psoriasis, meeting all 44 endpoints. The company is also conducting a Phase 3 trial in pediatric patients.
Eli Lilly has built $1.5 billion in pre-launch inventory of oral weight loss drug orforglipron ahead of an April 2026 FDA decision, while Phase 3 data showed the drug maintained weight loss after switching from injectables.
SCOPE 2026 in Orlando recognized innovation in clinical research with three awards programs, honoring Biogen's lupus webinar series, TrialScreen's site connection initiative, and Biorce's AI platform among 70 competing products.
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
Eli Lilly reported positive Phase 3 results for retatrutide showing up to 71.2 lbs average weight loss, while stockpiling $1.5 billion of oral drug orforglipron ahead of anticipated FDA approval in April 2026.
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.
Moderna and Merck announced median five-year follow-up data showing intismeran autogene in combination with Keytruda reduced the risk of melanoma recurrence or death by 49% in high-risk patients following complete resection.
The FDA approved tradipitant (Nereus), an oral NK-1 receptor antagonist, for prevention of motion-induced vomiting on December 30, 2025. The approval marks the first new pharmacologic treatment for motion sickness in over four decades.
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
Antibody-drug conjugates targeting TROP2 with topoisomerase I inhibitor payloads are currently marketed in breast and lung cancer, with over 100 such ADCs now in clinical trials for various malignancies including gastrointestinal tumors.
The FDA approved Zycubo (copper histidinate) on January 13, 2026, as the first treatment for Menkes disease in pediatric patients, following resolution of manufacturing compliance concerns that led to an initial rejection in September 2025.
