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FDA Clears Hikma Plant Corrective Actions

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FDA says Hikma Pharmaceuticals has sufficiently corrected GMP violations at its Portuguese drug manufacturing facility.

Positive Results in Gilead Zydelig Study

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Gilead says its Phase 3 study of Zydelig combined with bendamustine and rituximab for treating patients with relapsed chronic lymp...

FDA Orders Mfr. Pediatric Studies of Contrast Media

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FDA says it is requiring manufacturers of iodinated contrast media to study the potential for infants to develop underactive thyro...

Another CDRH Letter Challenges Marketing of Test for Consumers

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FDA continues its crackdown against laboratory-developed test makers, sending a letter to HarmonyX about its tests for antiplatele...

Bernie Sanders Grills Califf on Industry Ties

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U.S. presidential hopeful Bernie Sanders (I-VT) grills FDA commissioner-nominee Robert Califf about his relationship with the drug...

Feds Coordinate Dietary Supplement Enforcement

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Several federal agencies announce coordinated enforcement efforts against a number of dietary supplement manufacturers.

Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites Heritage Pharmaceuticals and Life Support Development.

ADE Reporting Violations at Heritage Pharmaceuticals

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FDAs New Jersey District Office warns Heritage Pharmaceuticals about violations of Postmarketing Adverse Drug Event Reporting requ...

Misinformation: PhRMA Blasts BMJ Trial Study

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PhRMA says a study on compliance with clinical trial reporting requirements published online by BMJ Open spreads misinformation an...

Alexion Pharma Receives Voucher for Strensiq

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Federal Register Notice: FDA issues a priority review voucher to Alexion Pharmaceuticals for Strensiq, a therapy for infantile- an...