Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.
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The Class I recall affects nearly 250,000 devices.
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
That means a 14-day regimen of the drug would translate to a price of $193,900, the company said on a conference call.
Pfizer Inc. and its German partner BioNTech SE said their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine.
Prosecutors, who are seeking a 15-year prison sentence, called Holmes’ fraud “among the most substantial white collar offenses Silicon Valley or any other district has seen.”
Pharmaceutical companies could be made to disclose prices and deals agreed for any products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord reviewed by Reuters.
Nearly half of the world’s population, or 3.5 billion people, suffer from oral diseases, the majority of them in low- and middle-income countries, the World Health Organization said on Thursday.
The companies hope pairing the capabilities of the two platforms will allow for the development of conditionally-activated investigational bispecific cancer therapies.
Astellas’s Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.