Curated news and analysis on clinical trials, drug approvals, and medical research.
At least 111 substances of unknown safety have been added to U.S. foods, drinks and supplements without alerting the FDA, exploiting a legal loophole in the "generally recognized as safe" standard, according to a new investigation.
Novo Nordisk announced a $506 million investment to expand its Athlone, Ireland manufacturing facility for oral GLP-1 drugs, following strong early uptake of Wegovy weight loss pills in the US market.
Insilico Medicine has formed a strategic partnership with Liquid AI to develop lightweight scientific foundation models for drug discovery and entered a drug development collaboration with China Medical System Holdings targeting CNS and autoimmune diseases.
Tempus AI and Merck announced an expanded multi-year collaboration to accelerate discovery and development of precision medicine biomarkers using AI and multimodal datasets, focusing on oncology and potentially broader therapeutic areas.
Scholar Rock plans to resubmit its biologics license application for apitegromab in spinal muscular atrophy following FDA reinspection of the Catalent Indiana fill-finish facility, with a U.S. launch anticipated in 2026.
Coya Therapeutics detailed plans for a Phase 2 trial of combination immunotherapy targeting neuroinflammation in ALS, following a four-patient study showing biomarker improvements and reported slowing of disease progression.
Amylyx Pharmaceuticals is advancing avexitide toward potential FDA approval for post-bariatric hypoglycemia, with Phase 3 LUCIDITY trial results expected in Q3 2026 and a cash runway extending into 2028.
ImmunityBio establishes wholly owned subsidiary in Saudi Arabia to distribute Anktiva for bladder and lung cancer across MENA region, following world's first lung cancer approval in the Kingdom less than a year after May 2025 meeting.
Major pharmaceutical and biotech companies are urging the Trump administration to withdraw two Medicare pricing proposals that would align U.S. drug prices with international benchmarks, arguing the mandatory models exceed government authority and threaten innovation.
Amgen shares have climbed 35% over six months, trading near $388, as analysts raise price targets following strong fourth-quarter 2025 results and expanding oncology pipeline programs including IMDELLTRA and LUMAKRAS.
The global cancer gene therapy market is projected to grow from $3.6 billion in 2023 to $16 billion by 2033 at a 16.1% CAGR, while the broader oncology market eyes $748 billion by 2035, driven by immunotherapy advances and targeted treatments.
New studies show SGLT2 inhibitors and GLP-1 receptor agonists reduce risks of kidney failure, cardiovascular events, and liver complications in patients with type 2 diabetes, with particularly strong benefits in those with cirrhosis.
The global oncology market is projected to nearly triple from $279.98 billion in 2026 to $748.17 billion by 2035, driven by rapid adoption of immunotherapy, checkpoint inhibitors, and cell therapies across solid tumors and hematologic cancers.
The FDA issued a Complete Response Letter for Atara Biotherapeutics' Ebvallo application, reversing its prior acceptance of the ALLELE trial design. Partner Pierre Fabre Pharmaceuticals has requested a Type A meeting to address the agency's concerns.
The AI in genomics market is estimated to grow from USD 1.97 billion in 2026 to USD 317.4 billion by 2040, while the drug discovery informatics market is expected to reach USD 11.18 billion by 2035, driven by machine learning integration and big data analytics.
University of Melbourne receives $2.1 million for quantum-enabled brain-on-chip platform for neurological diseases, while Evogene partners with Queensland University of Technology on AI-driven cancer therapeutics targeting chemotherapy resistance.
The FDA informed uniQure that Phase 1/2 study data for AMT-130 in Huntington's disease is insufficient to support a biologics license application, recommending a prospective, randomized, double-blind, sham surgery-controlled study instead.
Systematic review identifies shared molecular signatures in brain and blood for major depressive disorder, while separate study finds brain-enriched circRNA can predict SSRI treatment response.
New research shows 73% of AI users in clinical trials report the technology met or exceeded expectations, with 70% confirming improvements in data accuracy and 93% of organizations already using or investigating AI applications.
Sanofi's oral BTK inhibitor rilzabrutinib received orphan drug designation in Japan for IgG4-related disease and warm autoimmune hemolytic anemia, while also securing U.S. FDA breakthrough therapy designation for the rare anemia indication.
