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Drugmakers are asking the European Commission to clarify new requirements for factory acceptance and site acceptance testing, including when it is okay to perform only the factory tests. Read More
Endo International has agreed to buy Par Pharmaceutical from private equity firm TPG for $8 billion in a deal the companies say will put them in the top five firms in the U.S. generics market. Read More
The FDA is considering expanding access to naloxone to cut down on deaths from opioid overdoses and wants industry and others to weigh in on the clinical, legal and regulatory barriers to doing so. Read More
The FDA has dubbed AbbVie’s autoimmune disease treatment Humira an orphan drug for the investigational treatment of moderate-to-severe hidradenitis suppurativa — paving the way for the drug’s ninth indication and seven years added exclusivity. Read More
The agency is inviting web developers to tap into data on adverse drug events, recalls and labeling and assess their impact for drug research Read More
The project is expected to benefit more than 4,000 companies by relieving them of the job of monitoring the medical literature for these substances. Read More
The FDA may be considering new label warnings for type 2 diabetes drugs containing the active ingredients canagliflozin, dapagliflozin and empagliflozin, in the wake of reports linking the drugs to a serious blood condition. Read More
Washington State Gov. Jay Inslee has signed legislation allowing pharmacists to substitute biosimilars for brandname biologics, joining a growing list of states that have passed such laws. 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