FDA approval of pembrolizumab marks major shift in head and neck cancer treatment
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ...
Tag: Approval
Moderna withdraws application for US approval of combined flu-Covid shot | US news
Moderna said on Wednesday it had withdrawn an application seeking approval for its flu and Covid combination vaccine candidate after ...
Accelerated FDA Approval Makes Verastem Drug the First Therapy for Rare Type of Ovarian Cancer
A rare type of ovarian cancer that grows slowly and responds poorly to chemotherapy now has its first FDA-approved treatment, ...
New Antibiotics For UTI Gets FDA Approval- First In 30 Years
Millions of women worldwide suffer from painful urinary tract infections (UTIs), and a growing number of these infections have become ...
With approval, Alnylam enters the ATTR-CM drug race
Morning! Today, we have plenty of interesting content from yesterday’s STAT Breakthrough Summit East in New York. Also, Alnylam wins ...
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 ...
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 ...
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