FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
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April 27, 2015.
The industry continues to puzzle over FDA's proposed regulation of mobile medical apps (MMAs), writes Jill Wechsler.
Teva announces that it would pay up to $40 billion in cash and stock to acquire Mylan.
The European Medicines Agency releases findings from marketing authorization application analysis.
April 21, 2015.
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.
At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.
WHO says that results from clinical trials should be reported within 12 months of completion of the study
FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.
April 16, 2015.
April 16, 2015.
The grants will be offered to investigators conducting research in the field of PCSK9 biology.
Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.
Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.
GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.
March 31, 2015.
Janelle Starr was surprised to find this month's SXSW speakers talk about failure. But their failures are enlightening, and essential to their ultimate success.
16 March, 2015.
March 16, 2015.