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What is Clinical Hold and how do you deal with it? Muhammad Asim Niazi
March 05, 2025
A clinical hold is implemented for IND which is a drug stage under clinical trials to investigate its efficacy & safety, and has not been officially allowed to market & used by patients.
Rona Therapeutics Receives IND Clearance from FDA to Initiate Phase 2 Study of RN0361: an APOC3 Targeted siRNA for Management of Hypertriglyceridemia PR Newswire
March 17, 2025
Rona Therapeutics Inc.announced the clearance of an IND by FDA for RN0361-an APOC3 targeted siRNA therapeutic for SHTG and FCS treatment.
SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE PharmaSources.com
February 18, 2022
SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research...
FDA Clears Pardes IND Application for COVID Antiviral Candidate contractpharma
February 04, 2022
PB-0451 is currently being evaluated in a Phase 1 placebo-controlled study in healthy volunteers evaluating safety, tolerability, and pharmacokinetics.
iBio Advances Lead COVID Vax Program IBIO-202 contractpharma
January 27, 2022
Moving forward with IND-enabling challenge studies for its second-generation vaccine candidate targeting the nucleocapsid (“N”) protein.
US FDA clears Nuvation Bio’s application for solid tumour therapy Pharmaceutical-Technology
January 24, 2022
The company will start a trial of NUV-868 as a single agent and along with olaparib or enzalutamide in solid tumours.
Nuvation Bio Announces FDA Clearance of Investigational NDA for NUV-422 for the Treatment of Advanced Breast Cancer AmericanPharmaceuticalReview
December 09, 2021
Nuvation Bio Inc. announced that the FDA has cleared its investigational new drug (IND) application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of advanced breast cancer. The FDA accepted the Company's first ...
FDA Clears Pharmaxis Cancer Drug to Progress to Phase 2 Study in Liver Cancer AmericanPharmaceuticalReview
November 10, 2021
Clinical stage drug development company Pharmaxis Ltd (ASX: PXS) today announced that an Investigational New Drug application (IND) for a trial of PXS-5505 in hepatocellular carcinoma (HCC)...
Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA americanpharmaceuticalreview
June 08, 2021
Ortho Regenerative Technologies Inc, a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, announced that it has received a clinical hold letter from the U.S. FDA related to its ...
FDA Issues Draft Guidance on Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products americanpharmaceuticalreview
April 29, 2021
The U.S. Food and Drug Administration has issued the draft guidance “Nonclinical Testing of Individualized Antisense Oligonucleotide (ASO) Drug Products for Severely Debilitating or Life-Threatening Diseases - Guidance for Sponsor-Investigators.”

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