The Office of Tissue Advancement Therapies, a branch of the Center for Biologics Evaluation and Research of the FDA, has progressed toward the acceptance of Ampio Pharmaceuticals' Ampion for a viable treatment option for severe osteoarthritis of the knee. Read More »
Merck, which is known as MSD outside the United States and Canada, and Pfizer Inc. recently announced the acceptance for review of three New Drug Applications by the U.S. Food and Drug Administration. Read More »
The Food and Drug Administration has approved ALK's Biologics License Application for a sublingual immunotherapy tablet aimed at combating the negative effects caused by dust mite allergies. Read More »
The U.S. Food and Drug Administration has approved Noctivia nasal spray for adults who deal with nocturnal polyuria, a condition that causes overproduction of urine during the night. Read More »
The FDA has approved the New Drug Application from Teva Pharmaceutical Industries Ltd. and granted Priority Review for SD-809, a treatment for tardive dyskinesia. Read More »
The U.S. Food and Drug Administration recently reclassified Class I devices, which are antigen-based rapid influenza antigen detection systems that are meant to detect the virus from clinical specimens, to Class II devices that are subject to special controls, according to PRNewswire. Read More »
The U.S. Food and Drug Administration has granted Perrigo Co. final approval for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) 5 mg/1.5mg per 5 mL. Read More »
The U.S. Food and Drug Administration has approved deflazacort, a new treatment for Duchenne muscular dystrophy in patients 5 years and older. Read More »
The Lower Drug Costs through Competition Act created by the House Energy and Commerce Committee was taken off the committee’s fast track on Feb. 3 Read More »
Biotech company Amgen submitted an application to the U.S. Food and Drug Administration for Blincyto, a drug used in the treatment of lymphoblastic leukemia, to broaden its uses and treatments. Read More »
The European Commission has granted Eli Lilly & Co. marketing rights for Olumiant, a drug used to treat patients suffering with severe rheumatoid arthritis. Read More »
The U.S. Food and Drug Administration approved Amgen's Parsabiv for the treating of secondary hyperparathyroidism in adults with chronic kidney failure and is administered at dialysis locations throughout the country. Read More »
A U.S. appeals court suspended a permanent injunction on Praluent, a cholesterol management drug, allowing Regeneron Pharmaceuticals to once again manufacture, market, sell and ship the drug around the world. Read More »
PharmaSmart International, a specialist in blood pressure kiosks, announced that its machines meet new Centers for Disease Control guidelines. Read More »
Sanofi, a global leader in health care and medication distribution, has received FDA approval of Xyzal Allergy 24HR as an over-the-counter medicine. Read More »
Sanofi has received FDA approval of Xyzal Allergy 24HR, an over-the-counter option for those suffering with certain allergies. Read More »
The U.S. Food and Drug Administration released its final guidance on naming biologics and biosimilars. Read More »
ABBV-8E 12 -- a new Alzheimer’s treatment still in development -- received a fast-track designation from the U.S. Food and Drug Administration to be moved to clinical trials. Read More »
Relmada Therapeutics, a biopharmaceutical company that specializes in developing treatments for central nervous system diseases, received approval from the U.S. Food and Drug Administration to advance a new therapy to clinical trials. Read More »
The U.S. Food and Drug Administration has approved Linzess, a treatment for people suffering with chronic idiopathic constipation. Read More »
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