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Simplifying Regulatory Submissions with e-CTD and Digital Dossier Management Saher Haider
August 02, 2024
Employing e-CTD and digital dossier management systems will not only support faster submission processes but also improve the accuracy and reliability of the data presented to regulators.
Pfizer and BioNTech to extend rolling submission for Covid-19 vaccine Pharmaceutical-Technology
February 15, 2022
Pfizer and BioNTech are set to extend their rolling submission to the US Food and Drug Administration (FDA) for amending the emergency use authorization (EUA) of the Covid-19 vaccine to include children aged six months to four years.
Omeros Confirms Submission of Response to FDA Regarding the BLA for Narsoplimab in the Treatment of HSCT-TMA FirstWordPharma
January 20, 2022
Omeros Corporation (Nasdaq: OMER) today confirmed that earlier this month the company submitted to the U.S. Food and Drug Administration (FDA) its response to the Agency's Complete Response Letter (CRL) for narsoplimab...
Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine prnasia
December 17, 2021
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the submission of a New Drug Application (NDA)...
Noramco Announces Submission of Drug Master File for Lisdexamfetamine Dimesylate AmericanPharmaceuticalReview
December 06, 2021
Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug...
Heron Therapeutics Announces Submission of HTX-019 NDA for the Prevention of Postoperative Nausea and Vomiting to FDA Drugs
November 22, 2021
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs...
Novavax Announces Submission of Biologics License Application in South Korea for Approval of NVX-CoV2373 prnasia
November 16, 2021
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited (SK bioscience)...
Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years AmericanPharmaceuticalReview
November 08, 2021
Ocugen, Inc., a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that it has submitted a request to the U.S. Food...
Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Rolling Review Submission to European Medicines Agency AmericanPharmaceuticalReview
November 02, 2021
Novavax, a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission...
Akebia Announces Otsuka's Submission of Initial Marketing Authorization Application to the European Medicines Agency for Vadadustat for the Treatment of Patients with Anemia due to Chronic Kidney Dise prnewswire
November 01, 2021
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its collaborator, Otsuka Pharmaceutical Co., Ltd. (Otsuka)...