The contents section serves as a navigational ... products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced ...

The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA ... any action on the basis ...

The Phase 1b/2a study will assess the safety of CNP-103 in adults (aged 18-35) and pediatrics (aged 12-17) who have Stage III or newly diagnosed (within the last 6 months) T1D as well as C-peptide ...

The Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant ...

had accepted the company’s New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, a chronic pain condition affecting over 10 million adults in the U ...

The good news is that Investigational New Drug submissions and New Drug Applications continue to be above average, with the latter hitting a high not seen since 1999.

Please provide your email address to receive an email when new articles are posted on ... episodes and nighttime blood pressure (BP). The drug’s safety profile in this specific patient ...

The last decade has seen a “dramatic increase” in investigational new drug (IND) applications for cannabis-derived products, according to the U.S. Food and Drug Administration. In a paper ...

has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...

for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who ...