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© 2021 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2021 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
August 12, 2021
All eyes are watching closely to see how well Viatris and Biocon Biologics’ Semglee, approved by FDA on July 28, competes with Sanofi’s well-established, long-acting insulin analog, Lantus.
European Commission proposes new bio-defense preparedness plan.
August 03, 2021
In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, Richard Pazdur, director of FDA’s Oncology Center of Excellence, lashed out at the alarmists and urged continued support for this early access process.
August 02, 2021
July 30, 2021
FDA is on track this year to authorize a notable number of new molecular entities and important biotech therapies.
July 27, 2021
FDA acting commissioner Janet Woodcock has outlined FDA’s plan to “transition to standard operations” for U.S. inspections.
July 19, 2021
A draft report from parliament's cancer committee highlights the benefits that precision and personalized medicine offer.
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 13, 2021
Micki Hultquist, Vice President, Global Franchise Head at AstraZeneca, discusses the journey from a missed endpoint in TULIP-1 to a clinical success in TULIP-2
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.