Curated news and analysis on clinical trials, drug approvals, and medical research.
A stem cell therapy for geographic atrophy improved vision in a phase Ib trial, and the first gene therapy for optic neuropathies was administered. Next-generation anti-VEGF agents are also extending treatment intervals in retinal vascular disease.
The European Medicines Agency is enforcing clinical trial transparency and has launched a new vaccine information initiative, while a coalition of health professionals warns of suboptimal vaccination coverage across Europe. An analysis also shows that only a portion of EMA-approved medicines are available to NHS patients in England after additional assessments.
An Ontario investigation yielded nearly 1.7 tonnes of drugs valued at over $139 million and 21 people charged. Other probes in four U.S. states led to more arrests and seizures.
Researchers have discovered a novel broadly neutralizing antibody, 007, that targets the HIV-1 V3 glycan site in a glycan-independent manner, overcoming escape mechanisms. The antibody demonstrated robust neutralization of resistant viral strains, synergized with existing antibodies in humanized mice, and is now advancing preclinically with Vir Biotechnology. This breakthrough may guide next-generation vaccine strategies amid ongoing efforts to induce broadly neutralizing antibodies through novel immunogen designs.
Tortugas Neuroscience and Korsana Biosciences emerged with significant funding to advance clinical-stage pipelines targeting neurological and neurodegenerative diseases. Tortugas raised $106 million, while Korsana secured $175 million to develop therapies for conditions including Alzheimer's, schizophrenia, and epilepsy.
Governments in the UK, Australia, and New York City are overhauling planning rules to fast-track major infrastructure projects, from clean energy and transport to Olympic venues and street safety improvements. The UK has confirmed reforms to cut pre-application time by up to 12 months and save £1 billion, while Queensland is streamlining approvals for Brisbane 2032 Games projects, and New York City has proposed ballot measures to accelerate permits and contracts.
An 84-unit Bronx affordable housing project is the first to enter NYC's new expedited land-use review, requiring a council vote within 90 days. The plan aims to build 200,000 affordable homes and preserve 200,000 more.
A Cochrane review finds exercise for hip osteoarthritis reduces pain by 7 points on a 100-point scale, below the 12-point threshold for noticeable benefit. A survey shows 76% of physical therapy patients skip home exercises, citing forgetfulness and time constraints. A study reports only 22% of stroke and brain injury survivors receive intensive inpatient rehab, with disparities by race, insurance, and income.
Transcripta Bio raised $24M backed by Mayo Clinic and Omnimed for AI-driven neurological and neuromuscular therapies. The funds will support IND-enabling studies and clinical preparation for ASD and FSHD programs.
AI-driven drug discovery attracts major investment and partnerships: Galux closes $29M Series B, LG Chem partners with LabGenius on cancer antibodies, Cheiron raises $8M seed, and Peptris secures $7.7M. Galux also teams with AimedBio on BBB-crossing proteins.
Cell culture media bags, medical-grade PCR packaging, cold chain packaging, and Ireland sterile injectables CDMO markets are forecast to grow through 2035-2036, with CAGRs ranging from 9.2% to 11.8%.
Bristol Myers Squibb, Sanofi, and Pfizer have filed new patent infringement suits over drugs including Camzyos, Lantus, and abrocitinib, while the Federal Circuit denied Sarepta's rehearing bid in a Regenxbio DNA patent case.
FDA approved Novartis' Fabhalta for IgAN to slow kidney function decline. Phase III ALIGN data for Vanrafia showed ~34% slower eGFR decline vs placebo and were published in The Lancet.
The FDA approved Tzield for stage 3 type 1 diabetes, and the therapy was given to children in Canada for the first time. Research also advanced on engineered islets and stem-cell treatments.
The FDA has finalized the revocation of Orange B and proposed revoking Citrus Red No. 2, while exercising enforcement discretion to permit ‘no artificial colors’ claims on foods that avoid petroleum‑based dyes. The actions are part of a broader initiative to phase out synthetic dyes and fast‑track natural alternatives.
Japan's transport ministry has created a fast-track approval scheme for certain US-made passenger cars, allowing them to be sold in Japan without additional domestic testing. The move implements Japan's commitments under a tariff pact. The announcement was made on February 16, 2026.
NEOK Bio dosed first patients in Phase 1 trials of lead bispecific ADCs NEOK001 and NEOK002 for advanced solid tumors. The candidates target B7-H3/ROR1 and EGFR/MUC1, with initial data expected in 2027.
The FDA has alerted medical device manufacturers that the nitrosamine impurity MNP was detected in certain combination products containing rifampin. The agency outlined manufacturer responsibilities for assessing and controlling nitrosamine risks and highlighted available guidance documents.
A recent global analysis shows oncology dominates clinical trial activity in 2025, while Phase II attrition rates dropped to 26%—the lowest in four years. The US remains the leader in investigator sites, but China is the fastest-growing market. Obesity research is poised to break into the top five most-studied diseases.
The Supreme Court will hear Hikma's appeal in the 'skinny label' patent fight over Amarin's Vascepa. The ruling could affect generic drug competition and investment in new drug indications.
