Janssen announced today that the FDA has granted Priority Review designation to its New Drug Application (NDA) for paliperidone palmitate, a 3-month atypical antipsychotic for treating schizophrenia in adults. The NDA for paliperidone palmitate 3-month injection was filed following a phase 3, internat...
Survodutide (BI 456906; Boehringer Ingelheim) was granted a breakthrough therapy designation by the FDA for treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis in adults. The decision is based on positive results from a ...
The FDA has granted Harmony Biosciences a Breakthrough Therapy designation for pitolisant, an investigational therapy for the treatment of cataplexy in patients with narcolepsy. The therapy was also granted a Fast Track designation as well, as there are many unmet needs in the realm of ...
The study authors noted that because of the positive results in the phase 2a trial, a phase 2b trial is in the works to analyze ‘1104 at a higher dose and a longer period of therapy among adults with active EOE throughout this year.1 “We are excited that the...