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3391 News Found

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 grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy
Drug Approval | August 25, 2025

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB


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


Vivo Bio Tech secures pre-clinical testing contract valued at Rs.10.75 Cr
News | August 22, 2025

Vivo Bio Tech secures pre-clinical testing contract valued at Rs.10.75 Cr

Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies


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


NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity
News | August 21, 2025

NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity

NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity


Skyhawk Therapeutics and Merck KGaA strike $2 billion deal to discover novel RNA for neurological disorders
News | August 20, 2025

Skyhawk Therapeutics and Merck KGaA strike $2 billion deal to discover novel RNA for neurological disorders

Skyhawk Therapeutics enters into an option agreement to grant Merck KGaA, Darmstadt, Germany, exclusive global rights to drug candidates pursued under the collaboration upon option exercise


Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial
News | August 19, 2025

Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial

According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million