Today, Vanda issued a letter to FDA Commissioner Robert M. Califf, MD, regarding the September 18, 2024 CRL in reference to Vanda's NDA for tradipitant for the treatment of gastroparesis. The full ...
Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the supplemental New Drug Application for ORPATHYS® (savolitinib) has been granted approval by the China National Medical Products ...
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As ...
After Vanda Pharmaceuticals’ phase 3 miss and FDA rejection for its stomach disorder candidate, CEO Mihael Polymeropoulos, ...
Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the supplemental New Drug Application for ORPATHYS ® (savolitinib) has been granted approval by the China National Medical ...
Johnson & Johnson (NYSE: JNJ) and Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced today that they have entered into a definitive agreement under which Johnson & Johnson will acquire all ...
In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between ...
The excimer laser complements the ZEISS VISUMAX 800 with ZEISS SMILE pro, extending ZEISS' LVC market leadership with ...
Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an ...
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