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Paris-based AB Science, a developer of tyrosine kinase inhibitors, received an FDA warning letter for failing to report adverse events promptly and lapses in clinical trial monitoring. Read More
A Montana compounder was hit with a 17-observation Form 483 due to issues with its sterile processing, contamination controls and other GMPs. Read More
A whistleblower’s willingness to wear a wire added $7 million to her share of the Endo Pharmaceuticals False Claims Act settlement over its painkiller Lidoderm. Read More
Canadian drugmaker Valeant Pharmaceuticals is buying Egypt’s largest drugmaker, Amoun Pharmaceutical, for about $800 million — giving the firm a platform for further expansion in the region. Read More
Amgen is reporting a “clinically meaningful number” of patients showed complete remission in a Phase 2 study of its pricey drug to treat a rare strain of leukemia. Read More
Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More
In a bipartisan 28-2 vote, the Senate Appropriations Committee Thursday approved the fiscal year 2016 appropriations bill to fund the FDA, but at levels far below what President Barack Obama had requested. Read More