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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
October 01, 2021
FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.
September 27, 2021
The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.
Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.
September 21, 2021
Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.
September 20, 2021
FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.
September 17, 2021
Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.
September 10, 2021
The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.
September 02, 2021
A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.
August 31, 2021
FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.
August 24, 2021
FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.