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The House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill on Wednesday aimed at ending the abuse of citizen petitions to stall generic approvals. Read More
Teva Pharmaceuticals has been hit with a patent infringement suit in a Delaware district court by Switzerland-based Ibsa Pharmaceuticals and Altergon over its generic version of Ibsa’s hypothyroidism treatment Tirosint (levothyroxine). Read More
An FDA advisory committee voted on Wednesday to turn down Boehringer Ingelheim’s empagliflozin oral tablets in 2.5 mg doses for type 1 diabetes. Read More
One proposed pathway would allow states, wholesalers and pharmacists to submit plans to the FDA for importing prescription drugs approved by Health Canada. Read More
Another Duchenne muscular dystrophy gene therapy trial has been held up by the FDA following a serious adverse event in one patient. The agency halted Solid Biosciences’ trial of SGT-001 twice before due to reported serious adverse events. Read More
AstraZeneca and Nektar Therapeutics hit Aurobindo with a patent infringement suit in a Delaware federal court over Aurobindo’s generic version of their constipation drug Movantik (naloxegol). Read More
The approval is the first combined indication label and the first regulatory approval in the world for the pair to treatment chronic graft versus host disease in adults. Read More
The agency asked manufacturers to voluntarily recall another H2 blocker nizatidine, or Axid, if they find NDMA above the acceptable daily intake level. Read More