Press Releases
Page 1 • 12 itemsAccess critical pharma & biotech press releases. Stay ahead on drug approvals, clinical trials, M&A, and regulatory updates impacting global markets.
XtalPi-Enabled PEP08 PRMT5 Inhibitor Begins Phase I Cancer Trial Enrollment
XtalPi and PharmaEngine's AI-discovered PRMT5 inhibitor PEP08 starts Phase I solid tumor trial, marking major milestone in synthetic lethality cancer treatment.
SPONTAN Phase II Data Shows 10-Minute Onset Time, Meets FDA Requirements for Erectile Dysfunction Treatment
SPONTAN Phase II interim results demonstrate 10-minute median onset versus 60 minutes for oral vardenafil, meeting FDA pharmacokinetic requirements.
Ironwood Pharmaceuticals Survey Reveals Critical Gaps in Short Bowel Syndrome TPN Treatment at DDW 2026
Ironwood Pharmaceuticals presents DDW 2026 survey findings highlighting unmet needs in total parenteral nutrition therapy for short bowel syndrome patients.
Edwards Lifesciences RESILIA Tissue Shows 10-Year Durability in COMMENCE Aortic Trial Results
Edwards Lifesciences announces 10-year COMMENCE trial data demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.
Arrowhead Pharmaceuticals Receives TGA Approval for REDEMPLO (Plozasiran) in Australia for Rare Genetic Disorder
Arrowhead Pharmaceuticals gains Australian TGA approval for REDEMPLO (plozasiran), expanding global access for familial chylomicronemia syndrome patients.
BioMarin's PALYNZIQ Receives FDA Approval for Adolescent PKU Patients 12 and Older
BioMarin announces FDA approval of PALYNZIQ for adolescents 12+ with phenylketonuria (PKU), expanding treatment options for rare genetic disorder patients.
ROIS Expands to US Market as Global CDMO with FDA Approval for Injectable Drug Manufacturing
ROIS establishes US operations as global CDMO with FDA, EMA, and other major regulatory approvals for end-to-end injectable drug manufacturing services.
FDA Approves Travere's FILSPARI for FSGS Treatment in Adults and Children 8+
Travere Therapeutics receives FDA approval for FILSPARI to reduce proteinuria in FSGS patients aged 8 and older, expanding rare kidney disease treatment options.
UCB Acquires Candid Therapeutics for $2.2 Billion, Expanding T-Cell Engager Platform for Autoimmune Diseases
UCB's $2.2B acquisition of Candid Therapeutics brings novel T-cell engager technology for autoimmune diseases, marking major expansion beyond oncology applications.
a2 Milk Company Recalls Three Batches of a2 Platinum Infant Formula Due to Health Risk Concerns
a2 Milk Company voluntarily recalls three batches of a2 Platinum Premium USA infant formula for 0-12 months due to potential health risks to babies.
Vector Science & Therapeutics Files Patent for Microneedle Catheter Platform for Cancer Drug Delivery
Vector Science & Therapeutics secures IP protection for novel microneedle catheter technology designed to deliver cancer drugs directly into tumors.
Apotex Receives First Canadian Health Canada Approval for Generic Ozempic (Semaglutide) Alternative
Apotex becomes first Canadian pharmaceutical company to receive Health Canada approval for Apo-Semaglutide Injection, a generic equivalent of Ozempic.