Biogen has disclosed in a Wednesday Securities and Exchange Commission filing that it has been served a subpoena by the U.S. Department of Justice, which is seeking more information regarding the company’s overseas operations.
The FDA on Tuesday approved Ipsen’s Onivyde, when used in combination with three chemotherapeutic drugs, for the treatment of newly diagnosed patients with metastatic pancreatic adenocarcinoma.
The U.S. CDC plans to drop its five-day COVID-19 isolation recommendations under new guidance planned by the agency, the Washington Post reported on Tuesday.
Takeda Pharmaceutical’s therapy for an allergic inflammation of the esophagus has received approval from the U.S. FDA, the Japanese drugmaker said on Monday, capping a years-long regulatory process.
The CEOs of Bristol Myers Squibb, Johnson & Johnson and Merck testified Thursday before the Senate health committee, defending the high U.S. prices that Americans pay for prescription drugs compared to other countries based on patient value and the need to fund innovation and R&D costs.
The U.S. Food and Drug Administration has placed a clinical hold on Iovance Biotherapeutics’ lung cancer therapy trial after a patient death, the company said on Wednesday.
Apple on Tuesday appealed a decision to ban imports of its watches based on a complaint from medical monitoring technology company Masimo (MASI.O), after U.S. President Joe Biden’s administration declined to veto a government tribunal.
Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.
In a watershed U.S. regulatory milestone, the MAPS Public Benefit Corporation announced Tuesday that it has submitted a New Drug Application to the FDA for an investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder.
The FDA on Thursday approved Takeda’s recombinant ADAMTS13, now to be marketed as Adzynma, for the treatment of the rare blood disorder congenital thrombotic thrombocytopenic purpura—the biopharma company’s second approval in as many days.
