Senti Biosciences Secures FDA Support for SENTI-202 Donor Selection Strategy in AML
Senti Biosciences gains FDA backing for SENTI-202 donor selection strategy in relapsed/refractory AML, with 50% complete remission rates tied...
China Filed 3,073 IND Applications in 2024. The West Hasn’t Noticed What That Number Actually Means.
China's CDE accepted 3,073 IND applications in 2024, up from 70 in 2015. For global trial sponsors, that seismic...
The Alzheimer’s Agitation Approval That Should Rewrite How We Think About Antipsychotics in Geriatric Psychiatry
Auvelity's FDA expansion into Alzheimer's agitation—peak sales now projected at $8B—exposes how long antipsychotics dominated a space where safer...
BeOne Medicines Got Caught Running a Blood Cancer Ad That Outran Its Own Data
FDA flagged BeOne's Brukinsa TV ad 'Clarity' for misleading visuals—BeOne's third OPDP enforcement letter in under 18 months. Here's...
ZUSDURI Shows 64.5% Disease-Free Rate at 36 Months in Bladder Cancer Trial
ZUSDURI demonstrates 64.5% disease-free rate at 36 months in bladder cancer trial, offering durability without maintenance therapy for recurrent...
Upstream Bio Caps COPD Study, Redirects to Phase 3 Design
Upstream Bio caps COPD Study enrollment at 400 participants and pivots to Phase 3 design around quarterly dosing for...
Voyager’s VY1706 cuts tau 64% in primates with no safety issues
Voyager's VY1706 achieves 64% tau reduction in primates with no safety issues, clearing preclinical path for human trials later...
Oruka Reports 63.5% PASI 100 Rate for ORKA-001 at Week 16 in Psoriasis
Oruka's ORKA-001 achieves 63.5% PASI 100 rate at Week 16 in psoriasis, exceeding typical IL-23 inhibitor performance at midpoint...
Avalo’s abdakibart achieves 42.5% HiSCR75 response in hidradenitis suppurativa trial
Avalo's abdakibart achieves 42.5% HiSCR75 response in hidradenitis suppurativa trial, the highest absolute improvement reported in comparable Phase 2...
Oral semaglutide achieves 21.6% weight loss in early responders, doubles mobility gains
Oral semaglutide achieves 21.6% weight loss in early responders and nearly doubles mobility gains versus placebo in OASIS 4...