NDA

LANNETT ANNOUNCES FDA COMPLETES REVIEW OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR BIOSIMILAR INSULIN GLARGINE

01/26/2022

–FDA States Pivotal Clinical Trial May Proceed, Trial Expected to Commence By March 2022– Excerpt from the Press Release: PHILADELPHIA, Jan. 21, 2022 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that they have completed the safety review of the Investigational New…

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Harbour BioMed Announces Dosing of First Patient of Two Phase I Trials for Next-Generation Anti-CTLA-4 Antibody HBM4003

01/07/2022

Excerpt from the Press Release: CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, Jan. 4, 2022 /PRNewswire/ — Harbour BioMed (“HBM”, HKEX: 02142) announced that, its next generation anti-CTLA-4 fully human heavy-chain only antibody (HCAb), HBM4003, has completed the first dosing of first patient in two phase I trials for the treatment of advanced hepatocellular…

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Rubius Therapeutics to Highlight the Power of its RED PLATFORM®, Significant Advances Across Red Cell Therapeutic Oncology Pipeline and New Type 1 Diabetes Program at Platform and Pipeline Day

12/21/2021

Highly Versatile and Programmable RED PLATFORM Enables Multiple Modalities to Target Different Immune Pathways Across a Range of Diseases Demonstrated Tolerance Induction with Bystander Suppression in Type 1 Diabetes Preclinical Program with Findings Translatable to Multiple T Cell-Mediated Autoimmune Diseases Advancing Next-Gen Artificial-Antigen Presenting Cells (aAPCs) with Loadable MHC Class 1 Platform, Enabling Presentation of…

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Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with Chemotherapy as First-Line Treatment for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

11/09/2021

Excerpt from the Press Release: SAN FRANCISCO and SUZHOU, China, Nov. 4, 2021 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application…

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