Press Releases
Page 10 • 12 itemsAccess critical pharma & biotech press releases. Stay ahead on drug approvals, clinical trials, M&A, and regulatory updates impacting global markets.
Leerink Partners Initiates Medincell Coverage with Outperform Rating Following UZEDY Risperidone LAI FDA Approvals
Leerink Partners initiates Medincell coverage with Outperform rating as UZEDY risperidone LAI gains FDA approval for schizophrenia and bipolar disorder treatment.
Getinge Receives CE Mark for Cardiohelp II ECLS System and EU MDR Approval for Intergard Synergy Vascular Graft
Getinge AB achieves major regulatory milestones with CE mark for Cardiohelp II ECLS system and EU MDR approval for Intergard Synergy antimicrobial vascular graft.
Karyopharm Phase 3 SENTRY Trial Results Selected for ASCO 2026 Late-Breaking Presentation in Myelofibrosis
Karyopharm's Phase 3 SENTRY trial in myelofibrosis earns prestigious late-breaking oral presentation slot at ASCO 2026, signaling potential breakthrough results.
Allogene Therapeutics Expands Cemacabtagene Ansegedleucel Phase 2 ALPHA3 Trial to South Korea and Australia
Allogene Therapeutics receives regulatory clearance to expand pivotal Phase 2 ALPHA3 trial of cemacabtagene ansegedleucel to South Korea and Australia markets.
Biocon Receives Health Canada Approval for Denosumab Biosimilars Bosaya and Vevzuo
Health Canada approves Biocon's denosumab biosimilars Bosaya and Vevzuo as alternatives to Prolia and Xgeva for osteoporosis and cancer treatment.
Cigna Healthcare Adds Accord BioPharma's IMULDOSA Biosimilar to Preferred Coverage Plans
Cigna Healthcare now covers IMULDOSA (ustekinumab-srlf), Accord BioPharma's biosimilar to STELARA, under commercial plans effective April 15, 2026.
BriaCell Bria-OTS+ Shows Preserved Quality of Life in Phase 3 Metastatic Breast Cancer Trial at AACR 2026
BriaCell's Bria-OTS+ maintains quality of life in heavily pretreated metastatic breast cancer patients, with new biomarker data presented at AACR 2026.
Pharmaceutical Isolators Market Reaches $7.82 Billion as EU GMP Annex 1 Drives Manufacturing Safety Requirements
The global pharmaceutical isolators market hits $7.82 billion, driven by EU GMP Annex 1 regulations and rising HPAPI production demands through 2031.
Mabwell Achieves First PIC/S GMP Compliance Certification from Jordan FDA for Biopharmaceutical Manufacturing
Mabwell's T-mab subsidiary passes Jordan FDA GMP inspection, marking first PIC/S regulatory compliance for the Chinese biopharmaceutical company's manufacturing.
Implantica RefluxStop Device Shows Excellent Long-Term Safety in Landmark 602-Patient European Study
Implantica's RefluxStop acid reflux device demonstrates excellent long-term safety in largest real-world study of 602 patients across 22 European centers.
AskBio's Ametefgene Parvec Enters Phase II Trial for Parkinson's Disease Gene Therapy
AskBio advances Ametefgene parvec (AB-1005) to Phase II trials for Parkinson's disease using commercial-scale manufacturing at Viralgen facility.
Adagene's Muzastotug Shows 66.7% Response Rate in Triple Combination Therapy for Hepatocellular Carcinoma at AACR 2026
Adagene's muzastotug demonstrates superior efficacy in combination therapy for liver cancer, achieving 66.7% response rate versus 32.5% control in Phase 1b/2 trial.