Reuters Health Information

 
 
  • Alert Becton Dickinson's Combination Test for COVID-19, Flu Gets FDA Authorization A molecular test from Becton Dickinson that detects viruses that cause COVID-19 as well as influenza and produces result in 2-3 hours has been given emergency user authorization by the US health regulator, the company said on Friday.
  • Alert U.S. FDA Authorizes Use of Blood Plasma to Treat Coronavirus The U.S. Food & Drug Administration (FDA) on Sunday said it authorized the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the disease, a day after President Donald Trump blamed the agency for impeding the rollout of coronavirus vaccines and therapeutics for political reasons.
  • FDA Approves Test That Can Detect Coronavirus in Minutes The US Food and Drug Administration granted the approval under its Emergency Use Authorization. Abbott said it will start distribution next week and will ramp up manufacturing to 50,000 tests per day.
  • Merck's Biosimilar to AbbVie's Humira Wins FDA Approval The U.S. Food and Drug Administration approved Merck & Co Inc's biosimilar to AbbVie Inc's blockbuster rheumatoid arthritis treatment Humira (adalimumab), the health agency said on Tuesday.
  • Alert FDA Approves Allergan's Avycaz for Two Types of Pneumonia Allergan Plc said on Thursday the U.S. Food and Drug Administration had approved the drugmaker’s antibiotic Avycaz to treat two types of pneumonia caused by drug-resistant bacteria.
  • Alert FDA Approves Mylan's Copy of Allergan's Vaginal Cream Mylan NV said the U.S. Food and Drug Administration had granted it the approval for a generic version of Allergan's Estrace cream for vaginal atrophy.
  • Alert Britain's Creo Receives Speedy FDA Approval for Its Endoscopic Device Britain's Creo Medical Group said its device to remove cancerous lesions in the bowel during an endoscopy had received U.S. approval much quicker than it planned, shaking up a timetable that had been focused on a European launch.
  • FDA Approves More Convenient Form of Roche Blood Cancer Drug U.S. health regulators on Thursday approved a new formulation of Roche's big-selling cancer drug Rituxan (rituximab) for three common types of blood cancers that allows for relatively quick administration via injection under the skin in place of a lengthy intravenous infusion, the company said.
  • Alert As Teva Wins U.S. Approval for GSK Advair Copy, Main Fight Yet to Come Israel's Teva Pharmaceutical Industries has won U.S. approval to market a copy of GlaxoSmithKline's best-selling Advair inhaler, although the real battle is still to come.
  • Alert FDA Expands Use of Pfizer's Best-Selling Pneumonia Vaccine Pfizer Inc said on Tuesday the U.S. Food and Drug Administration had expanded the use of its best-selling pneumonia vaccine, Prevnar, to adults aged 18 through 49.
  • Alert FDA Approves Allergan's Combination Therapy for Hypertension The U.S. Food and Drug Administration approved Allergan Plc's treatment for hypertension, the company said on Monday.
  • Alert FDA Authorizes Expanded Use of Medical Abortion Pill Mifeprex The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
  • Alert FDA Approves Anthim Injection to Treat Inhalational Anthrax FDA approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs.
  • Alert FDA Expands Use of Liver Drug to Subset of Patients The U.S. Food and Drug Administration has expanded the use of Gilead Sciences Inc's drug Harvoni (ledipasvir and sofosbuvir) to some hepatitis C patients in the advanced stage of cirrhosis, including those who have undergone liver transplant.
  • Alert Actavis Contraceptive Device Wins FDA Approval The U.S. Food and Drug Administration approved a hormonal contraceptive device on Friday that gives American women another reversible contraceptive choice as effective as sterilization.
  • Alert FDA Approves First Dermal Filler to Treat Acne Scarring The U.S. Food and Drug Administration approved the first dermal filler to treat scarring caused by acne, the most common skin disorder in the United States afflicting 40-50 million people.
  • Alert Baxter's Blood Disorder Drug Gets FDA Approval Drugmaker Baxter International Inc said the U.S. Food and Drug Administration had approved its drug Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for treating bleeding episodes in adults with acquired hemophilia A.
  • Alert Eye Implant Iluvien for Diabetic Macular Edema Clears FDA The FDA has approved eye implant Iluvien, from Alimera Sciences and pSivida Corp, for treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
  • Alert GE's 3D Mammography Device Gets U.S. FDA Approval General Electric Co's healthcare unit last week won U.S. Food and Drug Administration approval for its mammography device that produces three-dimensional images to detect breast cancer.
  • Alert FDA Approves New No-Calorie Sweetener U.S. regulators have approved a new non-caloric sweetener from Japan's Ajinomoto Co that can be used as a substitute for sugar or high fructose corn syrup in foods and beverages.