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) of Lupin’s Sacubitril and ...

Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications ... of our editorial content, we keep a strict ...

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...

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 ...

Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its proprietary, selective cortisol modulator, relacorilant, to treat ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

Corcept Therapeutics submitted a new drug application to the Food and Drug ... To further protect the integrity of our editorial content, we keep a strict separation between our sales teams ...

The Food and Drug Administration (FDA) has accepted a new drug application (NDA) with priority review for the investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) taletrectinib in the ...

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 ...

“We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray,” said Benjamin Esque, CEO of Corstasis Therapeutics Inc. “This milestone brings us closer to providing a simple, easy-to-use ...