US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
Applied Therapeutics: FDA Issues CRL For New Drug Application For Govorestat - Quick Facts
Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, for ...
CervoMed gains as dementia therapy granted FDA orphan tag
CervoMed (CRVO) stock rises as FDA grants Orphan Drug Designation for neflamapimod to treat frontotemporal dementia. Read ...
FDA probes blood cancer risk from bluebird's gene therapy, weighs regulatory action
The U.S. Food and Drug Administration is weighing the need for a regulatory action on bluebird bio's gene therapy for a rare ...
Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application
Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical ...
Applied Therapeutics’ NDA for govorestat receives negative response from FDA
Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter – CRL – for the New Drug Application – NDA – for ...
FDA approves Kebilidi for aromatic L-amino acid decarboxylase deficiency
The U.S. Food and Drug Administration has approved PTC Therapeutics' Kebilidi (eladocagene exuparvovec-tneq) for the ...
CervoMed Shares Rise 15% on FDA's Orphan Drug Designation for Neflamapimod
CervoMed shares rose 15% after receiving the Food and Drug Administration's orphan drug designation for neflamapimod, its frontotemporal dementia treatment. Shares were trading around $9.19. The stock ...
RFK Jr. ‘very well aligned’ with FDA mission on diet-related chronic disease: fmr. FDA official
A recent slew of food recalls is raising questions about the government’s ability to ensure food safety. Former FDA official ...
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With narcolepsy trial win, Axsome looks to revive former Pfizer antidepressant on the US market
Once a controversial European depression treatment that never made it to the U.S. | The treatment, which was once a Pfizer ...
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NIH leader afraid of COVID jabs, FDA adviser says Fauci admitted teens don't need vaccine
"I don’t want to have a heart attack" by taking any more jabs, relatively young agency branch chief tells undercover date.
Arrowhead: The Sarepta Partnership Validates RNAi Platform And Reduces Risk
Arrowhead Pharmaceuticals' stock rallied 17% due to significant pipeline developments and strategic partnerships. Learn more ...