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In a pair of recent lawsuits over proposed generics, Takeda has sued Apotex for allegedly infringing on its leukemia drug Iclusig (ponatinib) and Eli Lilly has filed suit against Dr. Reddy’s over alleged infringement of its osteoporosis therapy Forteo (teriparatide). Read More
As part of its commitments for reauthorization of its user fee programs, the FDA today officially launched a new initiative to help sponsors of new drug and biologics products incorporate real-world evidence (RWE) into their clinical trials. Read More
FDA Commissioner Robert Califf warned that the agency’s accelerated approval pathway is in dire need of reform during remarks at the 2022 National Organization for Rare Disorders (NORD) Breakthrough Summit held earlier this week. Read More
An FDA advisory committee recommended 14-1 yesterday that the FDA withdraw accelerated approval for Covis Pharma’s preterm birth drug Makena. Read More
The FDA has updated two compliance program guidances that provide instructions for agency staff conducting inspections, adding provisions for use of alternative inspection tools as well as bringing them into closer alignment with International Council for Harmonization (ICH) quality guidelines. Read More
The FDA has postponed its decision date on Travere Therapeutics’ new drug application (NDA) for sparsentan by three months, pending an update of the drug’s risk evaluation and mitigation strategies (REMS) plan. Read More