Pharmaceuticals, Biotechnology and Life Sciences
The US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for AstraZeneca’s Imfinzi (durvalumab) for the treatment of…
The US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss…
FDA has announced updates to three final guidances, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB)…
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.
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.
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.
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.
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.
When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what…
Vectura Group confirmed on Thursday what its partner Hikma Pharmaceuticals said in its interim results statement about its abbreviated new drug application (ANDA) filing for a US generic version of Advair Diskus.