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Antera Therapeutics has drawn FDA scrutiny for marketing and selling Aralyte, a kit of capsules filled with liquid peanut protein, as a preventative treatment to keep children from developing peanut allergies. Read More
GlaxoSmithKline has filed an amicus brief in support of Bristol-Myers Squibb’s U.S. Supreme Court petition, which asks for a review of the California high court’s decision allowing plaintiffs outside the state to sue the drugmaker in the state’s court system. Read More
Mylan declined to voluntarily testify before a Senate committee on its settlement with the Justice Department over its misclassification of the EpiPen for a Medicaid drug rebate program. Read More
Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. Read More