Gottlieb: RFK Jr. ‘will cost lives’ if he follows through on health plans
Scott Gottlieb, who served as commissioner of the Food and Drug Administration (FDA) during President-elect Trump’s first ...
Cucumbers recalled across US over possible salmonella concerns
Cucumbers distributed to customers in 26 states and five Canadian provinces have been recalled due to possible salmonella, ...
Applied Therapeutics: FDA Denial Of Govorestat NDA As Problematic As It Was Unexpected
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
2 Excellent Healthcare Stocks to Hold Through the Next Decade
Although excellent medical care is always in high demand, the healthcare sector continuously evolves. Companies aren't ...
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 ...
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 ...
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 ...
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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 ...
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 ...
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 ...
FDA to Review Exelixis' Application to Expand Use of Cancer Drug
Exelixis plans to meet with the FDA's oncologic drugs advisory committee in March to discuss the drug's potential new uses. The meeting will review the safety and effectiveness of the cancer drug ...