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3405 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


Briefs: Mankind Pharma, Mangalam Drugs and Organics, Veerhealth Care and Shelter Pharma
News | August 25, 2025

Briefs: Mankind Pharma, Mangalam Drugs and Organics, Veerhealth Care and Shelter Pharma

Mangalam Drugs and Organics receives repeat export order worth $ 21, 81,040


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


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


Alembic receives USFDA final approval for Macitentan Tablets, 10 mg
News | August 19, 2025

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension