The agency wants Congress to intervene, saying it does not have adequate oversight powers to ensure the safety of the myriad cannabidiol products derived from hemp. Continue Reading CBD is short for…
Category: FDA Approval
FDA declines to grant accelerated approval for Eli Lilly’s experimental Alzheimer’s treatment
The US Food and Drug Administration declined to grant accelerated approval to an experimental Alzheimer’s drug, donanemab, and requested additional data from Eli Lilly and Company, the drug maker. More Alzheimer’s disease…
FDA Panel Recommends COVID-19 Booster Shots
(HealthNewsDigest.com) – On Friday, Sept. 17, the Food and Drug Administration’s (FDA) advisory panel rejected a proposal to give Pfizer COVID-19 vaccine boosters to the general public.
FDA Approves 3D-printed Airway Stents Developed by Cleveland Clinic Doctor
(HealthNewsDigest.com) – CLEVELAND: The U.S. Food and Drug Administration (FDA) has cleared patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea, M.D.
Swallowable Device to Detect Pre-cancerous Barrett’s Esophagus Receives FDA 510(k) Clearance
(HealthNewsDigest.com) – Investigators have developed the test for early detection of Barrett’s esophagus that offers promise for preventing deaths from esophageal adenocarcinoma.
FDA Bans 7 Cancer-Causing Food Additives
(HealthNewsDigest.com) – WASHINGTON (October 5, 2018)—The U.S. Food and Drug Administration today effectively banned seven cancer-causing chemicals added to a variety of food and beverages for artificial flavoring—from ice cream and baked goods, to gum and beer.
Cost of Clinical Trials for New Drug FDA Approval Are Fraction of Total Tab
(HealthNewsDigest.com) – Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health.
Memory Foam for Vascular Treatment Receives FDA Clearance
(HealthNewsDigest.com) – Shape Memory Medical recently announced FDA clearance for U.S. marketing of their IMPEDE Embolization Plug, a technology funded by NIBIB and created to block irregular blood vessels.
FDA Approved Non Surgical Balloon Weight Loss Method- patients Shed Up to 50 lbs
(HealthNewsDigest.com) – Americans spend almost 60 billion dollars annually in pursuit of weight loss with gastric bypass surgery being the most common type
T2 Biosystems Receives FDA Clearance to Market T2Bacteria Panel for Detection of Sepsis-Causing Pathogens
(HealthNewsDigest.com) – LEXINGTON, Mass., May 29, 2018 — T2 Biosystems, Inc. (NASDAQ:TTOO), today announced that it has received market clearance from the U.S. Food and Drug Administration (FDA) for the T2Bacteria® Panel….
FDA Warns About Illegal Use of Injectable Silicone for Body Contouring and Associated Health Risks
(HealthNewsDigest.com) – SILVER SPRING, Md., Nov. 14, 2017 — The U.S. Food and Drug Administration today issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement….
FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
(HealthNewsDigest.com) – SILVER SPRING, Md., Aug. 11, 2017 — The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida
FDA Approves New Treatment to Reduce the Risk of Breast Cancer Returning
(HealthNewsDigest.com) – SILVER SPRING, Md., July 17, 2017 — The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer.
FDA Unveils Plan to Eliminate Orphan Designation Backlog
(HealthNewsDigest.com) – SILVER SPRING, Md., June 29, 2017 — Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog….
FDA Investigates Findings of Hepatitis A Linked to Frozen Tuna
(HealthNewsDigest.com) – SILVER SPRING, Md., June 2, 2017 — The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), are assisting state and local officials in assessing the risk of hepatitis A virus exposure from contaminated frozen tuna
FDA Approves New Novo Nordisk Treatment for Patients with Hemophilia
(HealthNewsDigest.com) – PLAINSBORO, N.J., May 31, 2017 — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN®(Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.
FDA Approves First Cancer Treatment for Any Solid Tumor With a Specific Genetic Feature
(HealthNewsDigest.com) – SILVER SPRING, Md., May 23, 2017 — The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
FDA Approves Drug to Treat ALS
(HealthNewsDigest.com) – SILVER SPRING, Md., May 5, 2017 — The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
FDA Approves Urea Cycle Disorder Treatment for Use in Children as Young as Two Months
(HealthNewsDigest.com) – DUBLIN, IRELAND – May 1, 2017 – Horizon Pharma plc (NASDAQ: HZNP), – today announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) to expand the age range for RAVICTI® (glycerol phenylbutyrate)….
Novartis Receives FDA Approval for Rydapt® in Newly Diagnosed FLT3-mutated Acute Yeloid Leukemia (AML)
(HealthNewsDigest.com) – EAST HANOVER, N.J., April 28, 2017 — Novartis announced today the US Food and Drug Administration (FDA) has approved Rydapt® (midostaurin, formerly PKC412) for two indications.