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The FDA’s Oncologic Drugs Advisory Committee cleared the way for a new combination treatment aimed at providing curative therapy for patients with previously untreated large B cell lymphoma.
The Biden administration has asked Congress for $7.2 billion in funding for the FDA for fiscal 2024 — an approximately 10 percent increase over what the agency received in fiscal 2023.
Responding to FDA Commissioner Robert Califf’s recent remarks regarding the value of advisory committee (AdComm) votes, two major industry advocates offered slightly different takes on the question.
More than 10 percent of drugs marketed with an Accelerated Approval (AA) failed to include mention of the AA on the label, a new study has found. Read More
The FDA and the Federal Trade Commission (FTC) have launched a campaign against false or misleading information about biosimilars that “may constitute unfair or deceptive practices” leading to decreased confidence in biosimilars. Read More
Intercept Pharmaceuticals has resolved patent litigation against Apotex Pharmaceuticals and MSN Laboratories over their alleged infringement on Intercept’s intellectual property protections for its liver disease drug Ocaliva (obeticholic acid). Read More