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Pharmaceutical Technology on MSNFDA approves Eton’s application for hydrocortisone oral solutionEton Pharmaceuticals’ new drug application (NDA) for Khindivi, an oral solution of hydrocortisone, has received US Food and ...
Novo Nordisk NOVO.B-2.41%decrease; red down pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a ...
XP 8121 is a combination drug meant to better control hypothyroidism, in part by moving its common therapy, levothyroxine, ...
Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.
Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about ...
Based in part on these results, the company announced earlier this month that it had filed a new drug application for elinzanetant with the U.S. Food and Drug Administration. According to ...
Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June ... “I am very pleased with the new FDA approval goal date of June 4, 2025, for our Ketamine ...
Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. The Melbrourne, Australia-based biopharmaceutical company said Friday that the ...
Aldeyra plans to resubmit the new drug application with new trial data later this year. Perspective from Darrell E. White, MD The FDA issued a complete response letter for the resubmission of the ...
Kura Oncology and Kyowa Kirin submitted data from the KOMET-001 trial, which the agency will review and decide whether to approve the drug by Nov. 30.
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