The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
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MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority TagMerck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the phase 3 CABINET pivotal study of ...
Harmony Biosciences' Wakix shows promise for significant revenue growth. Find out why HRMY stock’s profitability and pipeline ...
An executive order designating cartels as terrorist organizations will expand prosecutors' jurisdictions, affect relations ...
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
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J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy UseJohnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for ...
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