Research Investigational New Drug Applications – What You Need To Know
FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

DCGI claims India on course to become global drugs hub
Speaking at the Indian Drug Manufacturers' Association (IDMA) Annual Conclave, Somani said, "We are getting the applications of the investigational new drugs. Earlier, there used to be hardly 5-10 applications. At present, there are 23 applications in the pipeline for the investigational new drug and this is a great achievement of our country." (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 14, 2022 Category: Pharmaceuticals Source Type: news

Characteristics and Adverse Events of Patients for Whom Nifurtimox Was Released Through CDC-Sponsored Investigational New Drug Program for Treatment of Chagas Disease - United States, 2001-2021
This report describes the treatment of Chagas disease using nifurtimox. (Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - March 10, 2022 Category: American Health Tags: Chagas Disease (Trypanosoma cruzi Infection) MMWR Morbidity & Mortality Weekly Report Drug Therapy Source Type: news

Blueprint Medicines Completes Acquisition of Lengo Therapeutics
Expands Blueprint Medicines' lung cancer pipeline with LNG-451, a highly selective brain-penetrant precision therapy targeting EGFR exon 20 insertion mutations Investigational New Drug application for LNG-451 submitted to U.S. FDA by Lengo Therapeutics ... Biopharmaceuticals, Mergers & Acquisitions Blueprint Medicines, Lengo Therapeutics, precision therapy, NSCLC (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 30, 2021 Category: Pharmaceuticals Source Type: news

Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-422 for the Treatment of Advanced Breast Cancer
NEW YORK, Dec. 8, 2021 -- (Healthcare Sales & Marketing Network) -- Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today anno... Biopharmaceuticals, Oncology, FDA Nuvation Bio , breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 8, 2021 Category: Pharmaceuticals Source Type: news

Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations
Clinical / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators
CMC (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Doctor Who Distributed Unapproved Cancer Treatment Drug Convicted of More Than Two Dozen Felony Charges
FDA OCI, Benedict Liao, M.D., Wada Masao, Masao A. Wada, Fullerton CA, found, guilty, wire fraud, selling, cancer, misbranded drug, unapproved, new drug, Oeyama-Moto Cancer Research Foundation, Monterey Park CA, West Covina CA, Investigational New Drug, IND, Allesgen, FDA hold, (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - November 4, 2021 Category: Medical Law Authors: DOJ Source Type: news

FAScinate Therapeutics Inc. Submits Investigational New Drug (IND)...
Company Aims to Evaluate Safety, Tolerability, and Preliminary Efficacy of New Drug Candidate "KM-819"(PRWeb November 02, 2021)Read the full story at https://www.prweb.com/releases/fascinate_therapeutics_inc_submits_investigational_new_drug_ind_application_for_phase_2_clinical_studies_of_company_s_new_parkinson_s_disease_treatment/prweb18301841.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - November 2, 2021 Category: Pharmaceuticals Source Type: news

Theseus Pharmaceuticals Announces FDA Clearance of Investigational New Drug Application for THE-630, a Pan-Variant KIT Inhibitor in Development for the Treatment of Gastrointestinal Stromal Tumors (GIST)
CAMBRIDGE, Mass., Nov. 1, 2021 -- (Healthcare Sales & Marketing Network) --Theseus Pharmaceuticals, Inc. ("Theseus"), a biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercial... Biopharmaceuticals, Oncology, FDA Theseus Pharmaceuticals, targeted oncology, gastrointestinal stromal tumors (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 1, 2021 Category: Pharmaceuticals Source Type: news

Jon B. Cole, MD - 611902 - 05/05/2021
Failure to obtain Investigational New Drug Applications (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lauren R. Klein, MD, M.S. - 605544 - 05/06/2021
Failure to obtain Investigational New Drug Applications (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

U.S. FDA Accepts COUR Pharmaceuticals Investigational New Drug Application (IND) for a Proof-of-Concept Study for the Treatment of Primary Biliary Cholangitis (PBC)
Clinical study aims to investigate the safety and efficacy of CNP-104 in PBC patients with alkaline phosphatase (ALP) > 1.5x upper limit of normal (ULN) CHICAGO, Oct. 4, 2021 -- (Healthcare Sales & Marketing Network) -- COUR Pharmaceuticals, a biote... Biopharmaceuticals, FDA COUR Pharmaceuticals, Primary Biliary Cholangitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 6, 2021 Category: Pharmaceuticals Source Type: news

Pittsburgh-based biotech company on a growth path
NeuBase Therapeutics Inc., the Pittsburgh-based biotechnology company, has expanded in the city as well as in Massachusetts as it prepares for the investigational new drug application of its first candidate in its pipeline. NeuBase (Nasdaq: NBSE) recently opened its headquarters at The Riveria on Technology Drive in South Oakland amid other biotechnology firms and also opened a clinical and business development office in Cambridge, Massachusetts. And the company is continuing to develop its therapy… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 21, 2021 Category: Pharmaceuticals Authors: Paul J. Gough Source Type: news

Pittsburgh-based biotech company on a growth path
NeuBase Therapeutics Inc., the Pittsburgh-based biotechnology company, has expanded in the city as well as in Massachusetts as it prepares for the investigational new drug application of its first candidate in its pipeline. NeuBase (Nasdaq: NBSE) recently opened its headquarters at The Riveria on Technology Drive in South Oakland amid other biotechnology firms and also opened a clinical and business development office in Cambridge, Massachusetts. And the company is continuing to develop its therapy… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 21, 2021 Category: Biotechnology Authors: Paul J. Gough Source Type: news