FDA approves Sarepta’s controversial drug for Duchenne muscular dystrophy
(By Ed Silverman for STAT) he Food and Drug Administration on Monday approved1 a controversial drug to treat Duchenne muscular
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Legal Actions/Court Decisions
Colombia plans to proceed with price cut on Novartis cancer drug
(By Ed Silverman for STAT) After weeks of deliberations, the Colombia health minister is proceeding with plans to unilaterally lower
Read MoreFDA chastises companies for touting an unapproved opioid painkiller
(By Ed Silverman for STAT) File this under “What were they thinking?” At a time when selling opioid painkillers is
Read MoreLawmakers ask HHS to probe the Medicaid drug rebate program
(By Ed Silverman for STAT) In the wake of the controversy over EpiPen pricing,1 a group of lawmakers is demanding
Read MoreFDA panel votes to remove serious warning from Pfizer’s smoking cessation pill
(By Ed Silverman for STAT) Pfizer won a crucial battle in its quest to widen the market for its Chantix
Read MoreFDA weighs crackdown that could shut hundreds of stem cell clinics
(By Usha Lee McFarling for STAT) Scientists on Monday will urge the Food and Drug Administration to crack down on
Read MoreEpiPen maker under investigation for antitrust violations in New York
(By Ike Swetlitz for STAT) New York Attorney General Eric T. Schneiderman is investigating Mylan Pharmaceuticals for potential antitrust violations involving
Read MoreCalifornia court hangs out a welcome sign: Drug makers can be sued here
(By Ed Silverman for STAT) In a closely watched decision, the California Supreme Court ruled 4-3 Monday that hundreds of
Read MoreAnother Biosimilar Wins FDA Approval
U.S. Food and Drug Administration (FDA) approved Novartis’s Sandoz drug Erelzi (biosimilar copy of Amgen’s Enbrel) on Tuesday but it
Read MoreDoctors Sue Obama Administration for Forcing Them to Perform Gender Transition Procedures
(By Kelsey Harkness for The Daily Signal) Five states and a group of religiously-affiliated hospitals and physicians are suing the
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