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The race to create an abuse-deterrent version of a once-daily analgesic is heating up, with Purdue Pharma taking the lead in its competition with Zogenix’s controversial painkiller Zohydro ER. Read More
The FDA has asked Gilead Sciences to remove a sponsored link on Google that misrepresents the drugmaker’s hepatitis B drug, Viread, and omits risk information, the first such enforcement action since the agency issued guidance on character-limited advertisements last month. Read More
Some melanoma patients in the EU will now have access to GlaxoSmithKline’s Mekinist, following the European Commission’s approval of the drug as a single agent for patients with unresectable or metastatic disease fueled by a BRAF V600 mutation. Read More
Clinical research firm Clinipace Worldwide wants the FDA to sign off on a generic version of Merck’s osteoporosis drug Fosamax by declaring that three strengths of the drug were not discontinued for safety or effectiveness reasons. Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant have turned up quality control issues ranging from poor cleanliness to shoddy product testing and incomplete recordkeeping, the FDA says. Read More
Canadian generics maker Apotex’s Bangalore, India, plant has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More