Fondazione Telethon achieves milestone with Waskyra approval for Wiskott-Aldrich Syndrome
Fondazione Telethon announces the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European ...
Tag: Approval
Sarepta to seek approval for gene therapy in rare muscular dystrophy
An experimental gene therapy from Sarepta Therapeutics increased levels of the gene missing in an ultra-rare form of muscular dystrophy, ...
New acromegaly drug, Palsonify from Crinetics, wins FDA approval
SAN DIEGO — Crinetics Pharmaceuticals won Food and Drug Administration approval on Thursday for a drug for a rare and ...
Merck’s Injectable Version of Blockbuster Cancer Drug Keytruda Wins FDA Approval
A subcutaneously injected version of Merck cancer immunotherapy Keytruda is now FDA approved, a regulatory decision that gives patients a ...
FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns
The US Food and Drug Administration (FDA) is warning consumers to avoid sunscreens sold in whipped, mousse, or foam forms, ...
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 ...
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Moderna said on Wednesday it had withdrawn an application seeking approval for its flu and Covid combination vaccine candidate after ...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 ...
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