Precision’s Exciting HBV Trial: A Breakthrough for Hepatitis B Patients
Precision BioSciences has submitted Clinical Trial Applications (CTAs) to initiate a Phase 1 study for its in vivo gene...
Unpacking New FDA Guidance: Processes and Practices for BIMO Inspections
The U.S. FDA issued a draft guidance document, “Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections,” to streamline...
BioAlberta, AxialBridge Team Up to Empower Alberta Life Sciences Companies
BioAlberta has partnered with AxialBridge to support Alberta biotech and MedTech companies in expanding their clinical trials and R&D...
InBrain’s Groundbreaking Graphene-Based Brain Interface: A Revolutionary Breakthrough
INBRAIN Neuroelectronics has made history by performing the world’s first human procedure using its cortical brain-computer interface (BCI) in...
Viviani’s GLP-1 Implant Cleared for Human Trials in Australia: A Revolutionary Approach to Fighting Obesity and Overweight
Vivani Medical announces the approval of its clinical trial for a miniature GLP-1 implant, designed to offer comparable effectiveness...
TAGRISSO Approved for Unresectable Stage III EGFR-Mutated Lung Cancer
AstraZeneca’s TAGRISSO (osimertinib) has received US approval for treating adults with unresectable, Stage III EGFR-mutated non-small cell lung cancersmall...
New Hope for Hormone-Sensitive Prostate Cancer: Nubeqa® Expansion Application Submitted
Bayer submitted a supplemental application to the FDA for NUBEQA, an oral androgen receptor inhibitor combined with androgen deprivation...
Enterprise Therapeutics’ ETD001 Receives Rare Pediatric Disease Designation for Cystic Fibrosis
Enterprise Therapeutics, a biotechnology company specializing in respiratory disease therapies, has earned the “rare pediatric disease designation” (RPD) for...
Innovating FDA Approval for Novel Schizophrenia Treatment
Bristol Myers Squibb’s COBENFY has received FDA approval for treating adult schizophrenia. As a first-of-its-kind medication, COBENFY adopts a...
OHRP’s 7th Exploratory Workshop: Navigating AI in Clinical Trials
The Office for Human Research Protections (OHRP) recently hosted its 7th exploratory workshop, focusing on the increasingly pervasive topic...