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8349 News Found

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection
Drug Approval | August 26, 2025

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited


CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA
News | August 26, 2025

CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA

Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission


Parexel appoints Jim Anthony as CCO and President, Parexel Biotech
People | August 25, 2025

Parexel appoints Jim Anthony as CCO and President, Parexel Biotech

Anthony brings more than 25 years of pharmaceutical development and CRO experience to his expanded role


Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product
Biotech | August 25, 2025

Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product

Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing


FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema
Drug Approval | August 24, 2025

FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema

Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control


Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 Variant LP.8.1
Drug Approval | August 23, 2025

Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 Variant LP.8.1

All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone


Piramal Pharma Solutions opens dedicated OSD production capabilities at Sellersville, Pennsylvania site
News | August 22, 2025

Piramal Pharma Solutions opens dedicated OSD production capabilities at Sellersville, Pennsylvania site

The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site's capabilities


FDA lifts hold on Rocket Pharma's gene therapy trial
News | August 22, 2025

FDA lifts hold on Rocket Pharma's gene therapy trial

Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort