Top News

Aug 08, 2017
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
Jul 21, 2017
By BioPharm International Editors
A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.
Jul 10, 2017
By BioPharm International Editors
After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
Jun 29, 2017
By BioPharm International Editors
The agency announced a plan to eliminate its existing orphan designation request backlog.
Jun 12, 2017
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
Jun 08, 2017
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
May 15, 2017
By BioPharm International Editors
Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.
May 09, 2017
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
May 05, 2017
By BioPharm International Editors
Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.
May 05, 2017
By BioPharm International Editors
The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.
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