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RSS FeedPosted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
Posted by Michael Wonder on 29 Nov 2023
FDA investigating serious risk of T-cell malignancy following BCMA directed or CD19 directed autologous chimeric antigen receptor (CAR) T cell immunotherapies
28 November 2023 - The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR positive lymphoma, in ...
Posted by Michael Wonder on 07 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals
5 May 2022 - Today, the U.S. FDA has limited the authorised use of the Janssen COVID-19 Vaccine to individuals ...
Posted by Michael Wonder on 07 Feb 2022
FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
3 February 2022 - The U.S. FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) ...
Posted by Michael Wonder on 03 Dec 2021
AbbVie provides update on Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis in the U.S.
3 December 2021 - AbbVie today announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for ...
Posted by Michael Wonder on 01 Sep 2021
FDA requires warnings about increased risk of serious heart related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
1 September 2021 - Based on a completed U.S. FDA review of a large randomised safety clinical trial, we have concluded ...
Posted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...
Posted by Michael Wonder on 12 Jul 2021
FDA to announce new warning on J&J COVID vaccine related to a rare auto-immune disorder, report says
12 July 2021 - About 100 preliminary reports of Guillain-Barre syndrome have been detected after 12.8 million doses of the J&J ...
Posted by Michael Wonder on 07 Jun 2021
Innovative regenerative medicine therapies – patient safety comes first
3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...
Posted by Michael Wonder on 26 May 2021
Influencers say they were urged to criticise Pfizer vaccine
26 May 2021 - A disinformation effort to reduce public confidence in COVID-19 vaccines tried to enrol social media commentators in ...
Posted by Michael Wonder on 24 Apr 2021
FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 vaccine use following thorough safety review
23 April 2021 - Agencies underscore confidence in vaccine’s safety and effectiveness following data assessment; available data suggest potential blood clots ...
Posted by Michael Wonder on 19 Apr 2021
Fauci says he expects a decision Friday on whether the U.S. can resume using Johnson & Johnson’s vaccine
18 April 2021 - A decision about whether to resume administering the Johnson & Johnson COVID-19 vaccine should come this ...
Posted by Michael Wonder on 13 Apr 2021
U.S. FDA to scrutinise vaccine design behind COVID-19 shots linked to blood clots
13 April 2021 - With two COVID-19 vaccines now under scrutiny for possible links to very rare cases of blood ...
Posted by Michael Wonder on 13 Apr 2021
Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
13 April 2021 - The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation ...
Posted by Michael Wonder on 15 Mar 2021
Facebook to label all posts about coronavirus vaccines
15 March 2021 - Facebook, which has been criticised by politicians and researchers for allowing vaccine misinformation to spread on ...