Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...

Scilex (SCLX) announced that it will be filing today of a Supplemental New Drug Application, SNDA, with the FDA for ELYXYB in acute pain ...

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.

(RTTNews) - Johnson & Johnson (JNJ), Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with ...

Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...

Amgen receives US FDA approval for Lumakras in combo with Vectibix for chemorefractory KRAS G12C-mutated metastatic colorectal cancer: Thousand Oaks, California Monday, January 20 ...

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 ...