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Results For "biologic"

975 News Found

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys
Drug Approval | July 21, 2025

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths


ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia
Clinical Trials | July 21, 2025

ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia

Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials


WHO, ITU, and WIPO release new report on AI use in traditional medicine
News | July 15, 2025

WHO, ITU, and WIPO release new report on AI use in traditional medicine

The global TCIM market is expected to reach nearly US$ 600 billion by 2025


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025


AstraZeneca's Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial
Clinical Trials | July 14, 2025

AstraZeneca's Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial

Baxdrostat demonstrated a statistically significant and clinically meaningful reduction of systolic blood pressure compared with placebo


Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Drug Approval | July 13, 2025

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease


EU launches strategies to strengthen crisis readiness and health security
Policy | July 11, 2025

EU launches strategies to strengthen crisis readiness and health security

The Medical Countermeasures Strategy focuses on strengthening the EU’s preparedness for health crises


OneSource Specialty Pharma appoints Jeffrey Wong as CBO
People | July 08, 2025

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations


argenx advances clinical development of agonist antibody for myasthenic syndromes
News | July 04, 2025

argenx advances clinical development of agonist antibody for myasthenic syndromes

ARGX-119 is the sixth molecule developed through our Immunology Innovation Program to show proof-of-concept


India exports US$ 4,961 million pharmaceutical during April–May 2025: Pharmexcil
Policy | July 02, 2025

India exports US$ 4,961 million pharmaceutical during April–May 2025: Pharmexcil

Enhance strategies to drive sustainability, global Reach and digital transformation for a trillion-dollar future