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RSS FeedPosted by Michael Wonder on 13 Apr 2016
Merck announces FDA acceptance of biologics license application for investigational house dust mite sublingual allergy immunotherapy tablet
12 April 2016 - Merck today announced that the U.S. FDA has accepted for review the Biologics License Application (BLA) for ...
Posted by Michael Wonder on 12 Apr 2016
Physicians’ knowledge about FDA approval standards and perceptions of the “breakthrough therapy” designation
12 April 2016 - This survey study examines how well physicians understand the US FDA’s statutory definition of a “breakthrough” therapy, ...
Posted by Michael Wonder on 12 Apr 2016
Making the most of clinical trial data
12 April 2016 - Data from past clinical trials can be used to draw new conclusions about diseases and treatments long ...
Posted by Michael Wonder on 11 Apr 2016
FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
11 April 2016 - The U.S. FDA today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) ...
Posted by Michael Wonder on 11 Apr 2016
FDA grants priority review for Roche’s cancer immunotherapy atezolizumab in specific type of lung cancer
11 April 2016 - Roche today announced that the U.S. FDA has accepted the company’s Biologics License Application (BLA) and granted ...
Posted by Michael Wonder on 08 Apr 2016
Hikma’s ANDA for generic Advair Diskus accepted for filing by FDA
8 April 2016 - Hikma Pharmaceuticals today confirmed that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation ...
Posted by Michael Wonder on 08 Apr 2016
FDA advisory committee unanimously recommends accelerated approval of Ocaliva (obeticholic acid) for the treatment of PBC
7 April 2016 - Intercept Pharmaceuticals today announced that the U.S. FDA's Gastrointestinal Drugs Advisory Committee voted 17 to 0 to ...
Posted by Michael Wonder on 05 Apr 2016
FDA approves Inflectra, a biosimilar to Remicade
5 April 2016 - The U.S. FDA today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This ...
Posted by Michael Wonder on 05 Apr 2016
U.S. Food and Drug Administration approves Descovy (emtricitabine, tenofovir alafenamide), Gilead’s third TAF-based HIV therapy
4 April 2016 - Gilead Sciences, Inc. today announced that the U.S. FDA has approved Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 ...
Posted by Michael Wonder on 01 Apr 2016
Dynavax announces FDA acceptance for review of biologics license application and PDUFA action date for Heplisav-B
30 March 2016 - Dynavax Technologies Corporation announced today that the U.S. FDA has accepted for review the biologics license application ...
Posted by Michael Wonder on 01 Apr 2016
FDA's view on biosimilar product labeling
31 March 2016 - To address biosimilar labeling in particular, the FDA has issued detailed recommendations to industry in the “Labeling ...
Posted by Michael Wonder on 31 Mar 2016
New F.D.A. guidelines ease access to abortion pill
31 March 2016 - The FDA has relaxed the guidelines for taking a pill that induces abortion, reviving one of the ...
Posted by Michael Wonder on 30 Mar 2016
Newron receives complete response letter from US FDA for Xadago (safinamide mesylate)
29 March 2016 - Newron Pharmaceuticals and US WorldMeds announced today that a complete response letter from the FDA has been ...
Posted by Michael Wonder on 30 Mar 2016
OPKO Health receives complete response letter from FDA for Rayaldee new drug application
30 March 2016 - OPKO Health announces that the U.S. FDA has issued a complete response letter (CRL) to the company's ...
Posted by Michael Wonder on 30 Mar 2016
FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
30 March 2016 - The U.S. FDA today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive ...