.jpg){kind=tracking}
VETOQUINOL USA: Launches Flexprofen™
Generic carprofen chewable tablet developed to treat osteoarthritis symptoms in dogs
Latest News
MALLINCKRODT PLC: Mallinckrodt Lupus Phase 4 Clinical Study for Acthar® Gel (Repository Corticotropin Injection) Completes Enrollment in Difficult-to-Manage Population
Company continues focus on evidence expansion, potential utility of Acthar Gel in appropriate, underserved patients
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Anderson Advanced Ingredients® commends the most recent draft guidance by the U.S. Food and Drug Administration (FDA) titled "The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels".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
FDA drug approvals lag as other countries speed up process
Getting pharmaceutical drugs to market for treatment of diseases and conditions as quickly as possible has been a challenge for the U.S. Food and Drug Administration, even as other countries have sped up the process in favor of making new prescription drugs available to people sooner.
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).
20 food, dietary supplement recalls initiated
Food producers carried out 20 food or dietary supplement product recalls over the past two months, according to the U.S. Food and Drug Administration.
Duke University's McClellan cites FDA improvements
The FDA has made significant strides in drug safety reform over the past decade, says a leading authority from Duke University.
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."
Blood pressure monitor with EKG available for pre-order
The new Complete blood pressure monitor with EKG capability from Omron Healthcare, in partnership with AliveCor, is now available for preorder in the U.S. on Omron’s website.
Targeted therapy for metastatic bladder cancer approved by FDA
Balversa is the first targeted therapy to receive approval by the U.S. Food and Drug Administration for adult patients with advanced metastatic bladder cancer with the genetic alteration called FGFR3 or FGFR2 that progressed during or after platinum-containing chemotherapy.
.jpg){kind=tracking}
SPROUT PHARMACEUTICALS, INC.: The Food and Drug Administration (FDA) Determines that Women Taking Addyi May Safely Consume Alcohol
Sprout continues to work with FDA to ensure other elements of labeling are in line with new study findings
JANSSEN PHARMACEUTICALS, INC.: BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations
BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval
U.S. FOOD AND DRUG ADMINISTRATION: FDA issues final rule on safety and effectiveness of consumer hand sanitizers
Action completes a series of actions on the FDA’s review of OTC antiseptic active ingredients
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.
FDA Update: March medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Tentative FDA approval granted for generic Sernivo
The Food and Drug Administration (FDA) has given tentative approval for the generic version of Sernivo Spray 0.05% from Perrigo Company.
.jpg){kind=tracking}
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).