FDA
The U.S. FDA approved the use of Moderna’s and Janssen’s COVID-19 vaccines as a booster dose after their primary versions are completed.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 28, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.