STAT+: Soleno Therapeutics’ ‘life-changing’ drug nears approval decision
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to ...
Tag: Approval
Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder
Protein therapies for the eye must be dosed as frequent injections. Gene therapy offers one-time treatment, but must also be ...
Ono Pharma Drug Acquired in $2.4B Deal Wins FDA Approval for Treating Rare Type of Tumor
An Ono Pharma drug for a type of tumor affecting tissues of the joints is now FDA approved, giving the ...
Journavx, New Type Of Non-Opioid Pain Relief Drug Gets FDA Approval
The U.S. Food and Drug Administration (FDA) has approved Suzetrigine, a new non-opioid pain relief drug sold under the brand ...
New FDA Approval Adds Chronic Kidney Disease to Ozempic’s Label
GLP-1 drugs are being studied in a growing number of indications, and Novo Nordisk can now claim to have the ...
AstraZeneca, Daiichi Sankyo ADC Lands FDA Approval in Advanced Breast Cancer
A targeted cancer therapy from AstraZeneca’s alliance with Daiichi Sankyo is now FDA approved to treat certain cases of advanced ...
Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval
Syndax Pharmaceuticals has won FDA approval for a drug addressing advanced cases of acute leukemia carrying a particular genetic signature ...
PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain
An ultra-rare enzyme deficiency that keeps infants from achieving proper muscle function among other developmental delays now has its first ...
Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer
An Astellas Pharma drug designed to address a novel target has landed a highly anticipated FDA approval for a rare ...
Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD
The blockbuster Sanofi and Regeneron Pharmaceuticals drug Dupixent, already commercialized in several skin and lung disorders, has expanded its FDA-approval ...
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