A meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will take place on June 11 and June 12.
The Food and Drug Administration has been asked to investigate the e-cigarette company JUUL and its claims that it helps people to stop smoking.
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Pet lovers and veterinarians stay tuned. Texas-based SelenBio is soon to launch an effective breakthrough in helping to prevent gum disease in dogs and cats.
Optune®, a wearable, portable device from Novocure delivers Tumor Treating Fields (TTFields) to slow down or stop GBM cancer cells from dividing, and destroys the cancer without disrupting healthy, resting cells
KardiaMobile® is the Only Personal ECG that Delivers Multi-Dimensional Insight into a Patient's Heart
Ayala Pharmaceuticals, a clinical-stage company developing medicines for cancers that are genetically defined, announced today that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) for AL101, a potent and selective inhibitor of gamma secretase-mediated Notch signalling, for the treatment of ACC.
Food producers carried out 23 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
GATTEX is the only glucagon-like peptide-2 (GLP-2) analog approved that improves intestinal absorption in patients with SBS who are dependent on parenteral support (PS)
Despite a recent study which concluded that sunscreen enters the bloodstream after just one day of use, experts are urging the public to continue using sunscreen.
Five companies with products considered homeopathic have been found to be in violation of the FDA’s current good manufacturing practice regulations.
An anticoagulant injection, Fragmin, was approved by the Food and Drug Administration last week for pediatric patients.
The U.S. Food and Drug Administration sent letters to companies that produce homeopathic products claiming they were in violation of current good manufacturing practice (CGMP) regulations.
If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of kidney failure when added to current standard of care
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Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents.
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
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The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant.
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.
The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.
The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.
