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© 2021 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
July 14, 2021
A broad White House proposal to advance competition in major U.S. industries features several measures intended to make medicines more affordable for patients.
July 12, 2021
FDA acting commissioner Janet Woodcock has bowed to pressure and called on the HHS’s Office of the Inspector General to examine the review process for Biogen’s Alzheimer’s disease treatment, Aduhelm.
July 06, 2021
The Center for Biologics Evaluation and Research’s top priority is to approve biologics license applications (BLAs) to address vaccine hesitancy, according to CBER director Peter Marks.
June 30, 2021
The latest draft supports the creation of the Biden administration’s proposed Advanced Research Projects Agency for Health to accelerate research on cures for cancer, diabetes, Alzheimer’s and more.
June 22, 2021
CDER launches an initiative to gain more efficient and transparent operations of its advisory panels. Jill Wechsler reports.
June 10, 2021
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
June 09, 2021
The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.
June 07, 2021
The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.
June 01, 2021
Biopharma companies’ efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections.
May 26, 2021
FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.