You are here: Industry Insights > FDA

News List

Bayer lymphoma treatment speeds to FDA approval pharmafile
September 19, 2017
The FDA gave Bayer priority review for its treatment Aliqopa (copanlisib) in May of this year, and it quickly came to the judgement that the drug should be brought to patients with relapsed follicular lymphoma.
FDA puts clinical hold on Cellectis' CAR-T cell therapies biospectrumasia
September 19, 2017
Cellectis said it is working with clinical trial investigators and the FDA to resume the trials with an amended trial protocol that includes a lower dose of UCART123.
FDA Approves New Treatment for Adults with Relapsed Follicular Lymphoma americanpharmaceuticacreview
September 18, 2017
Aliqopa is a kinase inhibitor that works by blocking several enzymes that promote cell growth.
Mvasi approved as the first biosimilar in U.S. for the treatment of cancer europeanpharmaceuticalreview
September 18, 2017
Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers…
FDA panel gives GSK’s Shingrix unanimous approval pharmafile
September 15, 2017
The FDA’s advisory panel has given a strong signal that GSK’s Shingrix should not have too much difficulty getting full FDA approval, after voting swung 11-0 in favour of recommending the vaccine.
FDA-approved drug may block resistance to anti-angiogenesis therapy europeanpharmaceuticalreview
September 15, 2017
General study identifies targetable pathway that induces immunosuppressive environment in colorectal cancer…
FDA panel unanimously endorses Glaxo's Shingrix as $1B market duel nears fiercepharma
September 14, 2017
Marking a big step in its march toward potential approval, GlaxoSmithKline’s shingles vaccine Shingrix won the support of an FDA panel as experts touted its strengths over Merck’s Zostavax.
FDA accepts license application for Novartis' rituximab biosimilar pharmafile
September 13, 2017
FDA has accepted its Biologics License Application (BLA) for a proposed biosimilar version of Roche and Genentech’s Rituxan (rituximab)
FDA grants Breakthrough designation to Cemiplimab for CSCC europeanpharmaceuticalreview
September 11, 2017
Cemiplimab receives FDA Breakthrough Therapy Designation for advanced cutaneous squamous cell carcinoma…
FDA slams Pfizer unit that made EpiPens that failed during fatal emergencies fiercepharma
September 08, 2017
Mylan last spring recalled tens of thousands EpiPen injectors that had been manufactured by a Pfizer unit that were potentially faulty.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page