Wednesday, April 1, 2020

Wednesday, April 1, 2020

Latest News

LONGHORN VACCINES AND DIAGNOSTICS LLC: PrimeStore® MTM opens Sputum-free Molecular Screening for M. tuberculosis Infection

South Africa pilot study demonstrates new broad approach to identifying M. tuberculosis infected patients for further clinical investigation and treatment

VETOQUINOL USA: Launches Flexprofen™

Generic carprofen chewable tablet developed to treat osteoarthritis symptoms in dogs

BARONOVA, INC.: Announces FDA Approval of the TransPyloric Shuttle® (TPS®) Device

A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits

ANDERSON ADVANCED INGREDIENTS: Commends the FDA's updated allulose guidelines

Anderson Advanced Ingredients® commends the most recent draft guidance by the U.S. Food and Drug Administration (FDA) titled "The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels".

INNOVUS PHARMACEUTICALS, INC.: Announces FDA Approval of New ANDA for Supply of FlutiCare®

Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has approved abbreviated new drug application (“ANDA”) No. 208024 for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) owned by Akorn, Inc. (“Akorn”) (NASDAQ: AKRX). I

SYNERGISTIC THERAPEUTICS LLC: Obtains US Patent for Sublingual Ketamine Treatment for Depression

Synergistic Therapeutics LLC has recently announced issuance of a U.S. Patent for a sublingual antidepressant lozenge with Ketamine, used to treat anxiety, depression, major depressive disorder (MDD), and treatment-resistant depression (TRD).

BIOTECH: FDA Fast Tracking Innovative Breakthrough Therapies For Cancer Patients

A recent headline from a report released by Friends of Cancer Research, made the following eye-opening statement: "ONE OF THE BIGGEST TREATMENT BREAKTHROUGHS IN THE PAST FIVE YEARS WASN'T A DRUG, BUT A LAW."

U.S. FOOD AND DRUG ADMINISTRATION: FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

The U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.

U.S. FOOD AND DRUG ADMINISTRATION: USDA, EPA, and FDA Unveil Strategy to Reduce Food Waste

As part of the Trump Administration’s Winning on Reducing Food Waste Month, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) announced the release of a federal interagency strategy to address food waste.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

The U.S. Food and Drug Administration today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

NANOVIRICIDES, INC.: Provides Update on Pre-IND Meeting with the US FDA, GLP Safety/Toxicology Studies to Begin Soon, Multiple Kg Scale Drug Production Accomplished at Its Own Facility

NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to treat difficult and life-threatening viral diseases, reports that US FDA has responded to its request for a pre-IND meeting.

INNOBLATIVE DESIGNS, INC.: Innoblative's SIRA™ RFA Electrosurgical Device Receives FDA Clearance

Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S. Food and Drug Administration (FDA) clearance for its SIRA™ RFA Electrosurgical Device, a novel radiofrequency ablation (RFA) applicator that supplies energy for use in electrosurgery, specifically for intraoperative coagulation and ablation of soft tissue.

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

The U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory (Inova) of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness.

LSK BIOPHARMA: LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC)

LSK BioPharma (or "LSKB"), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or "Hengrui"), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, announced that the Companies have received FDA clearance to initiate a clinical trial in the United States in first-line patients with advanced hepatocellular carcinoma (HCC), evaluating the safety and efficacy of LSKB's rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, in combination with Hengrui's camrelizumab (SHR-1210), a humanized anti-PD-1 monoclonal antibody currently under NDA review in China for classic Hodgkin's Lymphoma (cHL).

FDA Health News