FDA clears VectorY’s PIONEER-ALS Phase I/II trial for ALS
VectorY Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application …
Post
-
-
Imvax to explore FDA pathway for glioblastoma candidate despite PFS miss
Imvax is preparing for discussions with US regulators about the next steps for IGV-001 in newly diagnosed glioblastoma (ndGBM) despite …
-
BMS delays Alzheimer’s readout for Cobenfy over “site irregularities”
Bristol Myers Squibb (BMS) has delayed the data readout from the Phase III ADEPT-2 trial of Cobenfy (xanomeline/trospium chloride) after …
-
Richard Padzur to leave FDA following recent CDER leadership shift
After less than a month in his new role as head of the US Food and Drug Administration’s (FDA) Center …
-
PolarityBio concludes SkinTE’s Phase III trial for diabetic foot ulcers
PolarityBio has completed the COVER DFUS II pivotal Phase III clinical trial of its autologous heterogeneous skin construct product, SkinTE, …
-
BMS delays Alzheimer’s readout for Cobenfy over “site irregularities”
Bristol Myers Squibb (BMS) has delayed the data readout from the Phase III ADEPT-2 trial of Cobenfy (xanomeline/trospium chloride) after …
-
Richard Padzur to leave FDA following recent CDER leadership shift
After less than a month in his new role as head of the US Food and Drug Administration’s (FDA) Center …
-
PolarityBio concludes SkinTE’s Phase III trial for diabetic foot ulcers
PolarityBio has completed the COVER DFUS II pivotal Phase III clinical trial of its autologous heterogeneous skin construct product, SkinTE, …
-
OCT DACH 2025: Geopolitics, trial equity and technology take centre stage
At Arena International’s Outsourcing in Clinical Trials (OCT) DACH 2025 conference, technology took centre stage, with emerging and established tools …
-
Vandria announces topline results from Phase I trial of VNA-318
Vandria has announced positive top line data from its first-in-human Phase I clinical trial evaluating VNA-318, a central nervous system …
-
FDA steps back from preclinical primate testing amid wider regulatory shift
The US Food and Drug Administration (FDA) has taken another step away from animal testing – this time through draft …
-
Regulatory factors in rare disease studies
The rare disease landscape poses myriad challenges for researchers, policymakers, and CROs, particularly in navigating its intricate regulatory environment. Rare …
-
Chronic hepatitis B therapeutics market to reach $3.2bn across 7MM in 2034
The CHB therapeutics market across the 7MM, comprising the US, 5EU, and Japan, is forecast to grow from $1.5bn in …
-
Oncology trials: Delivering precision and reliability in data management
Clinical trials for oncology are filled with data management complexities that must be carefully navigated, with challenges and solutions outlined …
-
Belite eyes tinlarebant approval after late-stage Stargardt success
Belite Bio is seeking US approval of its lead ophthalmology asset, tinlarebant, in Stargardt disease 1 (STGD1) following the positive …
