Why Is Precision Oncology-Focused Aprea Therapeutics Stock Trading Higher On Monday?
Monday, Aprea Therapeutics Inc APRE announced that the FDA has cleared its Investigational New Drug (IND) application for APR-1051. “APR-1051 is a next-generation inhibitor of WEE1 kinase, and based on its unique characteristics, we believe it will be best in class,” said Oren Gilad, President and…#apreatherapeuticsinc #fda #orengilad #aprea #clearanceofind #enrollment (Source: Reuters: Health)
Source: Reuters: Health - March 11, 2024 Category: Consumer Health News Source Type: news

Navigating the Investigational New Drug (IND) Application Process, Upcoming Webinar Hosted by Xtalks
In this free webinar, learn practical tips and recommendations for successfully navigating the investigational new drug (IND) application process, including actionable insights to enhance the chances of regulatory success. Attendees will get an overview of the required data to support the... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - February 15, 2024 Category: Pharmaceuticals Tags: FVT TDS Source Type: news

FDA Warns Exosome Maker for Marketing Outside Its IND
(MedPage Today) -- The FDA has warned Kimera Labs that it can't sell its exosome product for uses outside of its recently secured investigational new drug (IND) application. In a warning letter that was posted to the FDA's website last September... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - January 22, 2024 Category: American Health Source Type: news

Why Is Neuromuscular Disease Focused Entrada Therapeutics Shares Trading Lower Today?
Entrada Therapeutics Inc TRDA shares are trading lower after the company announced updates on ENTR-601-44 in Duchenne Muscular Dystrophy. The FDA previously notified Entrada that the Investigational New Drug (IND) application for the Phase 1 clinical trial of ENTR-601-44 had been placed on…#fda #entrada #dipaldoshi #entradatherapeutics #williamblair (Source: Reuters: Health)
Source: Reuters: Health - November 22, 2023 Category: Consumer Health News Source Type: news

Insilico Medicine receives IND approval for novel AI-designed USP1 inhibitor for cancer
Insilico Medicine ("Insilico"), a generative artificial intelligence (AI)-driven clinical stage drug discovery company, announced that the U.S. Food and Drug Administration (FDA) recently approved the initial investigational new drug (IND) application for ISM3091 for the treatment of patients with solid tumors. This is Insilico's first oncology program to advance to the clinical validation stage. (Source: World Pharma News)
Source: World Pharma News - June 2, 2023 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies
HORSHAM, Pa., May 2, 2023 – Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. These investigational CD20-directed autologous CAR-Ts have demonstrated promising overall and complete response rates in Phase 1 studies in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) in China, with the m...
Source: Johnson and Johnson - May 2, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Arbutus Biopharma shares decline as FDA puts hold on drug study application
The Bucks County company's investigational new drug application is for an experimental therapy to treat hepatitis B infections. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 26, 2023 Category: American Health Authors: John George Source Type: news

Kala Pharmaceuticals stock rockets nearly 300% after FDA OKs IND application for PCED treatment
Shares of Kala Pharmaceuticals Inc. KALA, quadrupled in very volatile trading Wednesday, after the biopharmaceutical company said the Food and Drug Administration accepted its investigational new drug (IND) application for KPI-012, its treatment of persistent corneal epithelial defect (PCED). With…#kpi012 #kala #spx (Source: Reuters: Health)
Source: Reuters: Health - December 28, 2022 Category: Consumer Health News Source Type: news

Clinical Use of Tecovirimat for Treatment of Monkeypox Clinical Use of Tecovirimat for Treatment of Monkeypox
Review the use of tecovirimat (Tpoxx), an antiviral approved by the FDA for treatment of smallpox, for treating monkeypox under an FDA-regulated Expanded Access Investigational New Drug mechanism.Morbidity & Mortality Weekly Report (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - December 7, 2022 Category: Infectious Diseases Tags: Public Health & Prevention Journal Article Source Type: news

Sofie to launch FAPI-PET phase II trial
Sofie Biosciences has received Investigational New Drug clearance for a phas...Read more on AuntMinnie.comRelated Reading: First patient imaged in Sofie's FAPI-PET trial Sofie receives nod to start trial for PET tracer Sofie submits IND application for pancreatic PET agent Sofie, Lantheus ink deal for prostate cancer imaging agent Jubilant inks deal to invest $25M in Sofie (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 2, 2022 Category: Radiology Source Type: news

Transcript: "Research Investigational New Drug Applications – What You Need To Know"
Research Investigational New Drug Applications – What You Need To Know Podcast Transcript (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 4, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: " Research Investigational New Drug Applications – What You Need To Know "
Research Investigational New Drug Applications – What You Need To Know Podcast Transcript (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 4, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Emalex Biosciences Announces $250 Million Financing Round to Advance Investigational New Drug for Tourette Syndrome
Clinical stage biopharmaceutical company completes upsized, oversubscribed Series D financing from leading life sciences investors CHICAGO, Nov. 3, 2022 -- (Healthcare Sales & Marketing Network) -- Emalex Biosciences announced the closing of an upsized... Biopharmaceuticals, Neurology, Venture Capital Emalex Biosciences, ecopipam, Tourette Syndrome (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 3, 2022 Category: Pharmaceuticals Source Type: news

Chewing to curb COVID
Penn Medicine will conduct a new clinical trial to evaluate the safety and efficacy of a chewing gum designed by School of Dental Medicine researchers to trap SARS-CoV-2 in the saliva. Chewing gum tablets containing plant material laced with the ACE2 protein are being evaluated in a clinical trial to see if they are safe and effective in trapping SARS-CoV-2 in the saliva. (Image: Kevin Monko/Penn Dental Medicine) A recently launched clinical trial at Penn Medicine will evaluate a new chewing gum designed by School of Dental Medicine researchers to trap SARS-CoV-2 in the saliva, potentially blocking transmission of COVID-...
Source: Dental Technology Blog - November 2, 2022 Category: Dentistry Source Type: news

Cumberland drug company raises $3M seed round to develop cannabis-derived lung treatment
A Cumberland drug company has raised $3 million in funding as it works toward gaining approval for a new cannabis-derived treatment for lung diseases. RS BioTherapeutics plans to use the capital from its second seed round to focus on developing a medication for chronic obstructive pulmonary disease, or COPD. Co-founder and Chief Strategy Officer Justin Molignoni said the company will apply for an investigational new drug application from the U.S. Food and Drug Administration and hopes to submit … (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - October 5, 2022 Category: Health Management Authors: Matt Hooke Source Type: news