Curated news and analysis on clinical trials, drug approvals, and medical research.
INmune Bio announced FDA alignment on Phase III registration program for XPro1595 in Alzheimer's disease and submitted regulatory packages for CORDStrom in rare disease treatment, marking key milestones toward commercialization.
Three interconnected life sciences infrastructure markets are experiencing significant growth driven by precision medicine adoption, increasing clinical trial activity, and advances in genomic diagnostics through 2035.
Isomorphic Labs released a 27-page technical report on IsoDDE, its new AI drug-discovery engine that outperforms existing models in predicting drug-protein interactions and antibody structures, but the proprietary system offers limited technical details.
The FDA removed the clinical hold on Intellia Therapeutics' MAGNITUDE-2 Phase 3 trial of nexiguran ziclumeran for ATTRv-PN, allowing patient enrollment and dosing to resume with enhanced safety monitoring.
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
Recent studies demonstrate significant advances in engineered immune cell therapies, including enhanced CAR-T cells for solid tumors through NR2F6 deletion and mass production of CAR-NK cells from cord blood stem cells capable of generating millions of tumor-killing cells.
NASA delayed its Artemis II lunar fly-around mission to April after a helium flow problem emerged with the Space Launch System rocket. The agency also announced a major overhaul of the Artemis program to add practice flights before attempting a crew landing.
Klothea Bio has initiated a Phase 1b clinical trial of AKL003, an alpha Klotho mRNA therapeutic designed to extend human lifespan. The randomized, placebo-controlled study is enrolling 21 healthy adults in Prospera, Honduras.
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
Neoadjuvant pembrolizumab achieved 71% pathologic complete response in desmoplastic melanoma patients, while lower-dose ipilimumab combination therapy showed improved survival and fewer side effects in advanced melanoma treatment.
Zimbabwe began rolling out lenacapavir, a twice-yearly injectable HIV prevention drug, on February 19 in Epworth. The program will initially target more than 46,000 people at high risk across 24 sites nationwide.
Gilead Sciences has agreed to buy immunotherapy cancer biotech Arcellx in a deal worth $7.8 billion, deepening its bet on cancer immunotherapy and its existing partnership with the company.
Abbott India will commercialize semaglutide, the diabetes drug behind Ozempic, under the brand name Extensior in India following a partnership with Novo Nordisk. The launch targets India's growing diabetes population of over 100 million people.
Pharmaceutical companies are increasingly partnering with biotechs developing RNA-targeting small molecules, driven by advances in RNA structural biology and the success of drugs like Roche's Evrysdi. The approach aims to address "undruggable" targets while offering oral availability advantages.
The FDA reversed an earlier refusal and agreed to review Moderna's seasonal flu vaccine application after the company revised its approach based on age groups, setting a decision date of August 5, 2026.
Summit Therapeutics will participate in three investor conferences in March 2026, following FDA acceptance of its BLA for ivonescimab in lung cancer with a PDUFA date of November 14, 2026.
The American Medical Association and University of Minnesota's Vaccine Integrity Project are creating an independent vaccine review system after major changes at the CDC raised concerns among public health experts.
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
Zydus Lifesciences received USFDA final approval for 32 mg bosentan tablets for pediatric PAH and Ammonium Lactate Cream, 12%, while launching an affordable respiratory device in India.
CAR T-cell therapy market advances with AI-driven manufacturing improvements and over 250 companies developing 500+ drug candidates, including breakthrough solid tumor treatments and GPC3-targeted therapies for hepatocellular carcinoma.
