The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
Barth syndrome (BTHS) is a rare genetic disorder primarily affecting males, characterized by a range of symptoms including cardiomyopathy, skeletal myopathy, and neutropenia. The condition is ...
US clinical-stage drug developer Stealth BioTherapeutics announced that the US Food and Drug Administration (FDA) has ...
SMC proteins can reverse direction, reshaping DNA and solving key scientific debates. This discovery could impact research on ...
Nuclear magnetic resonance (NMR) spectroscopy is a technique that detects the chemical environment of atomic nuclei by the absorption of radio-frequency electromagnetic radiation when in the ...
Merck and Eisai reported new data for a drug regimen of Keytruda and Lenvima. Elsewhere, AstraZeneca expanded in Canada and ...
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