Notice on withdrawal of New Drug Application in the US of GnRH antagonist Linzagolix
August 22, 2022 -- Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan, Chairman and CEO: Mutsuo Kanzawa) notifies that the New Drug Application (NDA) for the GnRH antagonist linzagolix originally discovered by Kissei for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 22, 2022 Category: Drugs & Pharmacology Source Type: news

Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
WALTHAM, Mass., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 22, 2022 Category: Drugs & Pharmacology Source Type: news

Calyptus Pharmaceuticals Announces FDA Approval of Cetrorelix Acetate for Injection, 0.25 mg/vial
PRINCETON, N.J., Aug. 19, 2022 -- (Healthcare Sales & Marketing Network) -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for an AP-rate... Biopharmaceuticals, Generics, FDA Calyptus Pharmaceuticals, Cetrotide, Cetrorelix (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 19, 2022 Category: Pharmaceuticals Source Type: news

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
TOKYO, Aug. 18, 2022. Astellas Pharma Inc. ( " Astellas " ) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ' s New Drug Application (NDA) for fezolinetant, an investigational oral, nonhormonal compound seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 18, 2022 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
If approved by the FDA, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause TOKYO, Aug. 18, 2022 -- (Healthcare Sales & Marketing Network) -- Astellas Pharma Inc. (TSE: 4503, President and C... Biopharmaceuticals, FDA Astellas Pharma, fezolinetant (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 18, 2022 Category: Pharmaceuticals Source Type: news