Five Approvals, Nine Expansions: What the EMA’s April CHMP Meeting Reveals About Where Global Drug Development Is Heading
EMA's CHMP recommended 5 new medicines and 9 indication expansions in its April 20–23 meeting — here's what the...
The Cognitive Penalty of ECT Has Always Been Its Ceiling — MST Just Removed It
CREST–MST in Lancet Psychiatry shows magnetic seizure therapy matches ECT remission rates with superior cognitive safety—reshaping convulsive therapy trial…
Biomea’s Icovamenib Shows Lasting C-Peptide Gains in T1D
In an open-label Phase 2 study of adults with Stage 3 type 1 diabetes, 12 weeks of the menin...
Intellia Announces Proposed Public Offering of Common Stock
Intellia Therapeutics launched a $150 million underwritten public offering of common stock, with a 30-day option for underwriters to...
Bioxodes’ BIOX-101 Shows Breakthrough ICH Trial Results
Final results from BIRCH, a 23-patient multicenter, randomized, open-label Phase 2a trial in spontaneous intracerebral hemorrhage, met the primary...
Structure to Present New Diabetes Combination Data at ADA
Structure Therapeutics will take an oral small-molecule GLP-1 receptor agonist into the ADA spotlight with Phase 2b ACCESS data...
FDA Fast Tracks Scancell’s Melanoma Drug After Phase 2 Data
Progression-free survival reached 77% at 20 months in the target HLA-selected population of Scancell’s Phase 2 SCOPE trial when...
ERAS-0015 Shows Surging Promise in KRAS Mutant Tumors
Unconfirmed overall response rates from early Phase 1 readouts of ERAS-0015, a once-daily oral pan-RAS molecular glue, were 62%...
BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
When the Vendor Consolidates, Sites Feel It First
WCG's acquisition of The Contract Network promises faster trial startup—but site coordinators know vendor mergers rarely simplify the contracts...