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 ...
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 ...
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 ...
Thanksgiving Food Recall List: List of Warnings Issued
People should be aware of certain products they may have in their pantry or refrigerator amid the ongoing recalls.
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VAT exemption for all prescription drugs
The Food and Drug Administration (FDA) recently updated its list of prescription drugs and essential medicines exempt from value-added tax (VAT), adding 16 new medicines for the treatment of cancer, ...
BioSpace20h
The Biggest Pharma Share Moves of the Year So Far
Eli Lilly topped the list of the 20 biggest pharmas by market cap with a more than 39% improvement year-to-date in its share ...
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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 ...
Carrots, ice cream and more items recalled by the FDA. Here's the list for November 2024
The FDA removed the following items from store shelves in November: HH Fresh Trading Enoki Mushrooms: Potential to be ...
CervoMed Announces Orphan Drug Designation Granted to Neflamapimod by U.S. Food and Drug Administration for the Treatment of Frontotemporal Dementia
Designation underscores significant unmet need in frontotemporal dementia and the potential role of neflamapimod in multiple neurologic ...
Weight-loss-drug makers’ stocks get a boost from new Biden coverage proposal, but will it hold up?
The stocks of companies that make the new class of drugs to treat obesity and manage diabetes were higher across the board ...
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 ...