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Drugmakers seeking approval of fidaxomicin generics to treat Clostridium difficile-associated diarrhea have two options for demonstrating bioequivalence, the FDA said. Read More
The UK’s drug pricing watchdog has recommended reimbursement for Eli Lilly’s lung cancer drug Alimta and Pfizer’s leukemia therapy Bosulif at discounted prices. Read More
The FDA recommends drugmakers implementing the structured product labeling format for risk evaluation and mitigation strategies start by assembling its experts in both areas. Read More