FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.
All posts by admin
FDA approves new vaginal ring for one year of birth control
FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy
The app uses basal body temperature readings to predict when a woman is most fertile to help her avoid conceiving on those days if using as a form of contraception
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)
As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).
"Country Favor Inc Issues Alert on Undeclared Sulfites in “Best Taste Brand Snack Ginger Sliced”
Country Favor Inc. of Maspeth, New York is recalling its 7 ounce packages of “Best Taste Brand Snack Ginger Sliced” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests
FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests
Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination
Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.
FDA approves treatment for two rare types of non-Hodgkin lymphoma
FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy
FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition