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.
An anticoagulant injection, Fragmin, was approved by the Food and Drug Administration last week for pediatric patients.
Five companies with products considered homeopathic have been found to be in violation of the FDA’s current good manufacturing practice regulations.
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.
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)
Food producers carried out 23 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
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.
KardiaMobile® is the Only Personal ECG that Delivers Multi-Dimensional Insight into a Patient's Heart
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
.jpg){kind=tracking}
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.
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.
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.
.jpg){kind=tracking}
POLYTECH Health & Aesthetics GmbH, a global leader in breast aesthetics, welcomes a recent statement by the FDA that textured breast implants will remain available in the US market, In opposition to the recent decision by the French health authority ANSM (Agence Nationale de Sécurité du Médicament) to ban 'macrotextured' and polyurethane coated implants from the French market.
Aidoc now leads the way in FDA approved AI solutions for radiologists
If approved by the FDA, pexidartinib would be the first and only approved therapy for tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and not amenable to improvement with surgery
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.
EYLEA improves diabetic retinopathy and prevents worsening disease that can lead to blindness
The U.S. Food and Drug Administration is now requiring its strongest warning to be used on several of the most commonly used prescription insomnia medicines.
