Curated news and analysis on clinical trials, drug approvals, and medical research.
Eli Lilly has stockpiled $1.5 billion in inventory for Orforglipron ahead of an expected FDA decision in April. The oral weight-loss pill aims to compete with Novo Nordisk's recently approved oral Wegovy.
CStone Pharmaceuticals has received FDA clearance for its IND application to initiate a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGFA, and CTLA-4, in patients with advanced solid tumors across nine cancer indications.
Eli Lilly's Retevmo (selpercatinib) demonstrated statistically significant event-free survival improvement in the Phase III LIBRETTO-432 trial for early-stage RET fusion-positive non-small cell lung cancer.
Worldwide Clinical Trials has completed its acquisition of Catalyst Clinical Research, expanding its oncology capabilities and functional service provider model. The combined organization employs approximately 4,400 professionals across more than 70 countries.
Compass Pathways' COMP360 synthetic psilocybin met primary endpoints in Phase 3 trials for treatment-resistant depression, with the company planning to submit a new drug application in Q4 2026.
The global antibodies market is projected to reach $667.8 billion by 2032 with a 12.9% CAGR, while high throughput antibody production services are expected to grow at 11.2% CAGR through 2033, driven by biopharmaceutical development and monoclonal antibody therapeutics demand.
Compass Pathways announced successful results from its second Phase 3 trial of COMP360 psilocybin for treatment-resistant depression, with highly statistically significant outcomes and plans for FDA submission in Q4 2026.
Eli Lilly's Retevmo demonstrated statistically significant improvement in event-free survival versus placebo in stage II-IIIA RET fusion-positive non-small cell lung cancer following curative therapy in the phase 3 LIBRETTO-432 trial.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
Juvenescence, a clinical-stage AI-enabled biotech company, has appointed Eileen Jennings-Brown as Chief Technology Officer and established new research offices at Masdar City in Abu Dhabi to advance its longevity therapeutics pipeline.
ExCellThera's cell therapy Zemcelpro (dorocubicel) has been granted NUB Status 1 in Germany, allowing hospitals to apply for temporary supplementary reimbursement. 220 German hospitals have expressed interest in offering the therapy in 2026.
Artificial intelligence is advancing cancer care through early detection tools and improved clinical trial predictions. A Carnegie Mellon spinout is developing AI to identify high-risk patients, while predictive analytics are helping pharmaceutical companies prioritize promising compounds in oncology trials.
Eli Lilly announced positive Phase 3 LIBRETTO-432 trial results showing Retevmo (selpercatinib) significantly improved event-free survival in patients with early-stage RET fusion-positive non-small cell lung cancer as adjuvant therapy.
Novartis announced final Phase III ALIGN trial results showing Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy, with a 2.39ml/min/1.73m² eGFR difference versus placebo at week 136.
Disc Medicine received a complete response letter from the FDA for bitopertin in erythropoietic protoporphyria, with the agency requesting Phase 3 APOLLO trial results before approval. The company expects to respond by mid-2027.
Gilead Sciences entered a definitive agreement to acquire Arcellx for $115 per share in cash plus a $5 contingent value right, representing an implied equity value of $7.8 billion. The acquisition provides Gilead with full control of anito-cel, an investigational BCMA-directed CAR T-cell therapy for multiple myeloma.
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
Researchers used a machine-learning tool to analyze 500,000 UK Biobank participants, providing the first population-scale evidence that insulin resistance is a risk factor for 12 types of cancer.
The drug development services market is projected to reach $31.5 billion in 2026, growing at 12.2% CAGR, while AI-designed drugs enter pivotal Phase III trials that will determine whether the technology can improve clinical success rates beyond the industry's persistent 90% failure rate.
Nucleome Therapeutics announces Dr. Michelle Morrow as CSO effective February 23, 2026, bringing two decades of drug discovery experience as the company advances lead candidate NTP464 toward IND enabling studies.
