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:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 21, 2021 Category: Biotechnology 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:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 21, 2021 Category: Pharmaceuticals Authors: Paul J. Gough Source Type: news
Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-BCMA-ALLO1, an Allogeneic CAR-T Candidate for Relapsed/Refractory Multiple Myeloma
SAN DIEGO, Aug. 30, 2021 -- (Healthcare Sales & Marketing Network) -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutic... Biopharmaceuticals, Oncology, FDA Poseida Therapeutics, multiple myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 30, 2021 Category: Pharmaceuticals Source Type: news
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
Recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Curium files IND application for prostate PET agent
Nuclear medicine firm Curium has submitted an investigational new drug (IND...Read more on AuntMinnie.comRelated Reading:
CMS simplifies Detectnet coding
Detectnet PET radiotracer gets permanent HCPCS code
RadioMedix, Curium win FDA clearance for Detectnet
Cu-64 DOTATATE PET could handle neuroendocrine tumors
RadioMedix, Curium file NDA for PET agent (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 24, 2021 Category: Radiology Source Type: news
