The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not ...
Explaining the decision to re-employ the current drug controller general of India, the health ministry has told the ...
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...