October 31, 2017
Novartis waits second indication Kymriah to reach more patients
Novartis said on Tuesday that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug…
Pharmaceuticals, Biotechnology and Life Sciences
Tag: FDA
October 17, 2017
FDA accepts supplemental BLA for AZ’s Imfinzi in certain lung cancer
The US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for AstraZeneca’s Imfinzi (durvalumab) for the treatment of…
October 16, 2017
The US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss…
October 4, 2017
FDA simplifies Institutional Review Board review requirements for physicians seeking patient expanded access
FDA has announced updates to three final guidances, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB)…
October 3, 2017
FDA accepts sNDA filing for Allergan’s pneumonia drug
The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Allergan’s Avycaz (ceftazidime and avibactam) for priority review.
September 27, 2017
Federal judge orders U.S. company to stop distributing unapproved drugs
FDA has reported that the federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.
September 12, 2017
Sandoz proposed biosimilar rituximab accepted for review by the FDA
Rituxan is used to treat blood cancers including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.
August 25, 2017
FDA OK’s Novo Nordisk’s diabetes drug
The U.S. Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease.
August 25, 2017
Jonathan Emord to take another fight with the FDA on Electroshock Devices
Attorney Jonathan Emord and his co-counsel Kendrick Moxon have added to their Citizen Petition of August 2016, against the FDA’s Proposed Order to reclassify and make more readily available the Electroconvulsive Therapy (ECT) Device used to give “shock-treatment.” The reclassification would make it easier for doctors to give the treatment, which – pointed out by Emord & Associates, P.C – is well-known as the punishment given actor Jack Nicholson in the movie One Flew Over the Cuckoo’s Nest.
August 22, 2017
Working to improve information on medication use during pregnancy
When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what…