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Results For "safety"

1412 News Found

atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression
News | July 04, 2025

atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression

atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.


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


Alembic Pharmaceuticals acquires Utility Therapeutics for $12 million to strengthen US footprint
News | July 03, 2025

Alembic Pharmaceuticals acquires Utility Therapeutics for $12 million to strengthen US footprint

The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market


Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy
News | July 03, 2025

Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy

ART-123 is a recombinant human thrombomodulin approved in Japan in 2008


Cadila Pharmaceuticals launches Bilacad Dex Syrup
News | July 02, 2025

Cadila Pharmaceuticals launches Bilacad Dex Syrup

A triple-action Formula for comprehensive respiratory relief


Glaukos receives EU MDR certification for iStent infinite
Medical Device | July 02, 2025

Glaukos receives EU MDR certification for iStent infinite

The iStent platform uses tiny surgical implants to lower eye pressure by restoring the eye’s natural fluid drainage system in patients with glaucoma


Zambon launches intravenous formulation of Fluimucil
Drug Approval | June 29, 2025

Zambon launches intravenous formulation of Fluimucil

The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile


FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels
Drug Approval | June 28, 2025

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access


European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME
Drug Approval | June 28, 2025

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME


Biocon Biologics receives Health Canada approval for Yesafili
Drug Approval | June 27, 2025

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data