Stories | FDA Health News

By Erianne Leatherman | Apr 20, 2019

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

By Press release submission | Apr 19, 2019

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

By FDA Health News Reports | Apr 19, 2019

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

By Pat Morris | Apr 18, 2019

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

Patients

By Press release submission | Apr 18, 2019

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

By Keri Carbaugh | Apr 16, 2019

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

By Keri Carbaugh | Apr 16, 2019

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.

SPROUT PHARMACEUTICALS, INC.: The Food and Drug Administration (FDA) Determines that Women Taking Addyi May Safely Consume Alcohol

Patients

By Press release submission | Apr 16, 2019

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

By Press release submission | Apr 15, 2019

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

By Press release submission | Apr 15, 2019

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

By Press release submission | Apr 13, 2019

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

By Press release submission | Apr 12, 2019

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

By FDA Health News Reports | Apr 12, 2019

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

By Keri Carbaugh | Apr 11, 2019

The Food and Drug Administration (FDA) has given tentative approval for the generic version of Sernivo Spray 0.05% from Perrigo Company.

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

By Press release submission | Apr 11, 2019

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

By Press release submission | Apr 11, 2019

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.

FDA grants De Novo review to LOADPRO spine sensor

By Keri Carbaugh | Apr 10, 2019

The U.S Food and Drug Administration granted a De Novo review for a device intended to be used in the spine.

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

By Press release submission | Apr 10, 2019

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