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TAKEDA PHARMACEUTICALS: U.S. FDA Approves GATTEX® (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)

By Press release submission | May 20, 2019

WEST CANCER CENTER: FDA-Approved, Innovative Treatment for Glioblastoma (GMB) Cancer at West Cancer Center

By Press release submission | May 16, 2019

DAIICHI SANKYO: FDA Oncologic Drugs Advisory Committee Votes in Favor of Daiichi Sankyo's Pexidartinib for the Treatment of Select Patients with TGCT, a Rare, Debilitating Tumor

By Press release submission | May 14, 2019

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BIOTIME, INC.: Announces Issuance of U.S. Patent for Method of Reducing Cavitation in Patients with Acute Spinal Cord Injury

By Press release submission | May 7, 2019

BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company developing cellular therapies for unmet needs, announced today the issuance of a Notice of Allowance for a patent from the United States Patent and Trademark Office (USPTO) for United States Patent Application No. 15/156,316 for a method of reducing spinal cord injury (SCI)-induced parenchymal cavitation in patients that have suffered an acute spinal cord injury.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

By Press release submission | May 6, 2019

The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

By Press release submission | May 6, 2019

On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults.

U.S. FOOD AND DRUG ADMINISTRATION: Vaccination Is the Best Protection Against Measles

By Press release submission | May 5, 2019

Measles is one of the most contagious respiratory diseases in the world that has the potential to be life-threatening.

ISAPS: Applauds U.S. FDA Allowance of Textured-Surface Breast Implant Sales

By Press release submission | May 4, 2019

FDA announces new efforts to protect women's heath and ensure the safety of breast implants

UPSHER-SMITH LABORATORIES, INC.: Unveils Educational Resources And Support Tools For Migraine Patients

By Press release submission | May 4, 2019

Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of its newly redesigned website for Qudexy® XR (topiramate) Extended-Release Capsules.

INVITAE CORPORATION: New Study From Invitae Highlights the Importance of Multigene Genetic Testing for Uterine Cancer Patients

By Press release submission | May 3, 2019

Results from one of the largest datasets in uterine cancer presented at The American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting

IVANTIS, INC.: Announces Groundbreaking 3 Year Results from FDA Clinical Trial; First Device in Minimally Invasive Glaucoma Surgical (MIGS) Category to Demonstrate Significant Long Term Reduction of Severe Major Surgeries for Glaucoma Patients

By Press release submission | May 2, 2019

First study of any kind showing a MIGS device achieving a statistically significant reduction in secondary incisional surgery; over 70% of patients remain free of medications

Out-of-pocket drug costs a key voter concern, new poll finds

By FDA Health News Reports | Apr 26, 2019

Lowering out-of-pocket costs for prescription drugs is among American voters’ top health concerns, a new poll by released by a drug company trade association concludes.

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

By Press release submission | Apr 24, 2019

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

MALLINCKRODT PLC: Mallinckrodt Lupus Phase 4 Clinical Study for Acthar® Gel (Repository Corticotropin Injection) Completes Enrollment in Difficult-to-Manage Population

By Press release submission | Apr 23, 2019

Company continues focus on evidence expansion, potential utility of Acthar Gel in appropriate, underserved patients

BIOTECH: FDA Fast Tracking Innovative Breakthrough Therapies For Cancer 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."

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

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

DAIICHI SANKYO: Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

By Press release submission | Apr 4, 2019

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib, an investigational FLT3 inhibitor, currently under Priority Review for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

U.S. FOOD AND DRUG ADMINISTRATION: FDA advances landmark policy changes to modernize mammography services and improve their quality

By Press release submission | Mar 27, 2019

Proposed rule would require breast density reporting, enhance the FDA’s ability to enforce mammography facilities’ compliance with standards

NEURONIX LTD: neuroAD™ Therapy System for Treatment of Mild-to-Moderate Alzheimer's Disease Considered by FDA Neurological Devices Advisory Committee

By Press release submission | Mar 26, 2019

Neuronix Ltd. announced that the U.S. Food and Drug Administration (FDA) Neurological Devices Advisory Committee met on March 21 to consider data and receive public comment about the neuroAD™ Therapy System, a non-invasive medical device for the treatment of mild-to-moderate Alzheimer's disease.

NEUROTROPE INC.: Neurotrope Comments On Biogen's Discontinued Phase 3 Trial In Alzheimer's Disease

By Press release submission | Mar 22, 2019

Neurotrope Inc. (Nasdaq: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today issued a statement on Biogen Inc.'s decision to discontinue its global Phase 3 trials of aducanunab in Alzheimer's disease.

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