Policy
The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.
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Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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For over three years, no interest has accrued on federal student loans and no payments were required. Soon, mandatory payments will resume, leaving workers with less money in the bank.
Following its initial lawsuit last month, Merck has now requested that a federal judge rule on its Inflation Reduction Act case against the Biden administration without a trial.
For closing its $8 billion acquisition of Grail without regulatory approval, the European Union has slapped Illumina with a record $476 million fine—the maximum sanction allowed under the EU’s rules.
Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.
Burjeel Holdings and BridgeBio Pharma ink partnership deal in rare genetic diseases with a plan to set up headquarters in Abu Dhabi.
The European Medicines Agency has widened its review of potential suicide risks associated with GLP-1 receptor agonists. The probe, which started July 3, is expected to conclude in November.
The biotech Monday announced a clinical hold on its HEMO-CAR-T candidate, which is being trialed for the treatment of acute myeloid leukemia, due to manufacturing concerns cited by the regulator.
The biotech will supply Canada with fewer doses of its coronavirus vaccine while reaching a financial agreement for the forfeiting of certain doses previously scheduled for delivery.
After an initial series of legal complaints in June, Novo Nordisk filed four new lawsuits Thursday against Florida and Tennessee pharmacies for allegedly selling products containing semaglutide.
Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry.