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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
January 26, 2022
Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.
January 12, 2022
The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).
January 05, 2022
FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.
January 03, 2022
FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.
December 17, 2021
FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone.
December 16, 2021
General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.
December 07, 2021
President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.
November 18, 2021
Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.
November 03, 2021
Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.
October 28, 2021
FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.