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How to register a drug into the market in China? ChatGPT/PharmaSources
November 08, 2023
Registering a drug for market approval in China involves a comprehensive and multi-step process that requires adherence to the country's regulatory requirements.
New treatment methods are expected to be created for ALS patients. Amylyx submitted NDA of AMX0035 in the United States PharmaSources/Yi
December 02, 2021
On November 2, Amylyx Pharmaceuticals announced that it had submitted a new drug application of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS) to FDA.
Formulation development of New chemical Entities (NCE’s) to commercialization Deepak Hegde
June 16, 2021
The process of taking a new drug from concept to clinic and eventually to commercialization involves several steps which traditionally occur in series.
US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review pharmaceutical-business-review
February 14, 2022
The US Food and Drug Administration (FDA) has accepted for review Spectrum Pharmaceuticals’ New Drug Application (NDA) for its therapy poziotinib.
Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update drugs
August 06, 2021
Marinus today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures associated with CDKL5 deficiency disorder (CDD)
Antengene Announces the Approval of First-in-Class Oral XPO1 Inhibitor Selinexor in South Korea for the Treatment of Relapsed or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma firstwordpharma
August 02, 2021
Antengene Corporation Limited today announced that through a priority review process, the South Korean Ministry of Food and Drug Safety (MFDS) has approved the company's NDA for the Orphan Drug-designated first-in-class oral inhibitor of XPO1.
Liquidia Resubmits New Drug Application for LIQ861 Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension drugs
May 24, 2021
Liquidia Corporation announced today that on May 7, 2021, it resubmitted its New Drug Application for LIQ861 for the treatment of pulmonary arterial hypertension.
Iterum Therapeutics Submits NDA for Oral Sulopenem americanpharmaceuticalreview
December 16, 2020
Iterum Therapeutics has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a ...
Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, No drugs.com
September 23, 2020
Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Pedmark...
Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access P drugs.com
September 23, 2020
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases today announced that it has submitted the first portion of its rolling New Drug ...

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