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

Clinical Use of Tecovirimat (Tpoxx) for Treatment of Monkeypox Under an Investigational New Drug Protocol - United States, May-August 2022
This report describes the safety of the use of Tecovirimat to treat monkeypox. (Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - September 15, 2022 Category: American Health Tags: Infection MMWR Monkeypox Morbidity & Mortality Weekly Report Safety Treatment Source Type: news

EARLY RELEASE: Clinical Use of Tecovirimat (Tpoxx) for Treatment of Monkeypox Under an Investigational New Drug Protocol - United States, May-August 2022
This report describes the safety of the use of Tecovirimat to treat monkeypox. (Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - September 9, 2022 Category: American Health Tags: Infection MMWR Monkeypox Morbidity & Mortality Weekly Report Safety Treatment Source Type: news

Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia
BOSTON and ATLANTA, Aug. 26, 2022 -- (Healthcare Sales & Marketing Network) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parki... Biopharmaceuticals, Oncology, FDA Inhibikase Therapeutics, imatinib , Chronic Myelogenous Leukemia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 26, 2022 Category: Pharmaceuticals Source Type: news

What It Really Feels Like to Have Monkeypox
Since the global monkeypox outbreak began in May 2022, more than 22,000 cases have been confirmed in countries around the world. More than 5,000 of those cases have been recorded in the U.S., with many clustered in hotspots including New York and California. The virus, which often results in a blister-like rash and spreads through close contact, has so far predominantly affected men who have sex with men. Even as cases tick up and monkeypox gains public attention, however, it can still be difficult to find information about testing, treatment, and vaccines. Many people who fear they are at risk or infected are left to seek...
Source: TIME: Health - August 1, 2022 Category: Consumer Health News Authors: Jamie Ducharme, Angela Haupt and Jeffrey Kluger Tags: Uncategorized healthscienceclimate monkeypox Source Type: news

Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations Guidance for Sponsor-Investigators
Clinical / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 14, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Promising New Depression Tx; Racially Skewed ADHD Dx; Effective Clozapine Monitoring
(MedPage Today) -- The FDA gave ANeuroTech positive feedback during a pre-investigational new drug meeting on the phase IIIb clinical program testing their drug ANT-01 as adjunctive therapy for major depression, the company announced. Is there... (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - July 6, 2022 Category: Psychiatry Source Type: news

Ceruvia Lifesciences Receives FDA Investigational New Drug Approval for Psilocybin Obsessive-Compulsive Disorder Program Phase 2 Trial
GREENWICH, Conn., June 27, 2022 -- (Healthcare Sales & Marketing Network) -- Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved its Investi... Biopharmaceuticals, Neurology, FDA Ceruvia Lifesciences, psilocybin, obsessive-compulsive disorder (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 27, 2022 Category: Pharmaceuticals Source Type: news