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FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products expresspharma
July 23, 2020
The US FDA is revising the guidance to reflect that FDA generally intends to exercise enforcement discretion with respect to IND and premarket approval requirements for certain HCT/Ps through May 2021.
Immutep Receives Second IND approval for Efti from FDA americanpharmaceuticalreview
March 10, 2020
Immutep has announced the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) for eftilagimod alpha (efti or IMP321).
Aravive Receives IND Clearance for AVB-500 Trial for Clear Cell Renal Cell Carcinoma americanpharmaceuticalreview
January 17, 2020
Aravive announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for investigation of the company’s lead candidate, AVB-500, for the treatment of clear cell renal cell carcinoma (ccRCC
OWP Announces Second IND Approval for Lamotrigine Liquid Oral Suspension Formulation americanpharmaceuticalreview
December 30, 2019
OWP Pharmaceuticals has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), and has submitted for U.S. patent protection ...
Navigen Announces FDA Clearance of IND Application to Initiate First-in-Human Studies for CPT31 americanpharmaceuticalreview
December 16, 2019
Navigen announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for the initiation of a Phase I study in healthy volunteers to ...
Linnaeus Announces FDA Clearance of IND Application for LNS8801 americanpharmaceuticalreview
September 26, 2019
Linnaeus Therapeutics announced the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug application (IND) for LNS8801 ...
FDA approves IND application for coeliac treatment europeanpharmaceuticalreview
August 21, 2019
The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.
Ascletis Received IND Approval and Management Outlook of 2019 and Beyond prnasia
August 06, 2019
Ascletis Pharma Inc. (1672.HK), an innovative R&D driven, commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and ...
I-Mab gets IND approval for TJC4 antibody biospectrumasia
July 15, 2019
TJC4 is a potential global best-in-class CD47 Monoclonal Antibody developed for the treatment of advanced malignant tumors
Bioinvent Receives IND Approval for Phase I/iia Trial of Anti-fcyriib Antibody americanpharmaceuticalreview
July 04, 2019
BioInvent has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with an Investigational New Drug (IND) application for a Phase I/IIa clinical trial of an immune-modulatory anti-FcγRllB antibody in combination with an anti-

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