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The FDA on Wednesday published a list for drug sponsors of surrogate endpoints they may consider in trials to support drug approvals or licensures. Read More
Two drugmakers targeted in a lawsuit over Tennessee’s opioid epidemic filed a third-party complaint against online “black market” drug distributors, alleging they’re responsible for the state’s opioid crisis. Read More
An advisory panel Wednesday recommended that the FDA collect more data before signing off on use of GlaxoSmithKline’s asthma drug mepolizumab for treating chronic obstructive pulmonary disease (COPD). Read More
The Senate Health Committee unanimously approved a bipartisan bill on Wednesday that would outlaw “gag clauses” that prevent pharmacists from telling patients a drug would be cheaper if they paid out of pocket instead of using their insurance. Read More
In the latest move by Novartis to protect its top selling multiple sclerosis drug Gilenya (fingolimod) from generic competition, the Swiss drugmaker filed lawsuits against dozens of drugmakers seeking to market Gilenya copies. Read More
Liquids or soft foods should only be used as vehicles for drug administration if they have no appreciable effect on drug performance, the FDA said in a draft guidance issued Tuesday. Read More