The JOBS Act and FDASIA show early signs of accelerating drug development.
As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.
Pharma and biotech companies, with the rest of the healthcare industry, must face change.
Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers.
Wanted: Aspiring authors to share technical and scientific solutions for biopharmaceutical processing.
America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report.
A QbD paradigm advances process understanding in development and manufacturing.
Affymax Inc. and Takeda Pharmaceutical Company Limited have decided to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions.
SGS has added a 12-bed, Biosafety Level 2-Q compliant, quarantine facility for viral challenge studies to its clinical pharmacology unit in Antwerp, Belgium.