Regulatory
Today, Astellas announced that after evaluating its gene therapy for patients with X-linked Myotubular Myopathy, it revised its eligible treatment population and any likely future product label.
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential approval.
As Omicron dominates the COVID-19 landscape, scientists are urging the FDA to reconsider how the agency defines immune responses.
Toxicities and concerning patient survival data sparked a U.S. Food and Drug Administration advisory committee to recommend shutting the door on single-arm clinical studies of PI3K inhibitors.
The COVID-19 pandemic will end one day and, when it does, some biopharma companies will need to revert to a more normal way of working with others.
Servier is poised to go to market soon after the Phase III trial of its proposed drug for leukemia closed with positive results.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Arcturus Therapeutics announced positive Phase III trial results for its mRNA vaccine candidate, ARCT-154, intended to prevent COVID-19 caused by the SARS-CoV-2 virus.
Gilead Sciences scored a legal victory regarding fraudulent HIV reimbursements, securing a court order against a number of clinics, labs and prescribers in Florida that were engaging in the alleged fraud.
The FDA has issued a Complete Response Letter (CRL) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) to Teva Pharmaceuticals and MedinCell.
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