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AE Analysis Finds Low Rate of T-Cell Malignant Neoplasms in CAR T Recipients

Only 11 cases of adverse events (AEs) were reported over a 6-year time frame, the investigators found, following administration of chimeric antigen receptor T-cell therapy (CAR T).

Novartis , Event-reporting-system , Kite-pharma , Image-credit , Chimeric-antigen-receptort-cell-therapy , Car-t , Jama-oncology ,

FDA Requires Boxed Warning for Risk of T-Cell Malignancies With Approved CAR T-Cell Therapies

The FDA has mandated that the boxed warning for all approved CAR T-cell therapies be updated to include the serious risk of T-cell malignancies.

Tisagenlecleucel-kymriah , Rahul-banerjee , Division-of-hematology , University-of-washington , Clinical-research-division , Fred-hutchinson-cancer-center , Adverse-event-reporting-system , Event-reporting-system ,

EU regulator finds no link between GLP-1s and suicidal thoughts

EU regulator finds no link between GLP-1s and suicidal thoughts
fiercepharma.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fiercepharma.com Daily Mail and Mail on Sunday newspapers.

Sanofi-soliqua , Eli-lilly-trulicity , Astrazeneca-byetta , European-medicines-agency , Obesity-medicine-association-angela-fitch , Pharmacovigilance-risk-assessment-committee , Novo-nordisk , Risk-assessment-committee , Eli-lilly , Event-reporting-system , Nature-journal ,

More than 100 US deaths linked to Ozempic and similar weight loss drugs - including 28-year-old who died from 'intestinal mass' and a pregnant woman, our analysis shows

The cases have been recorded in an FDA monitoring system used to track the safety of medicines used in the US, called FAERS.

Australia , Ohio , United-states , Toni-adamrovich , Eli-lilly-zepbound , Eli-lilly , Trish-webster , Event-reporting-system , Novo-nordisk , Dailymail , Health

The Dying Brain; Obesity Drugs and MS; NurOwn Tries Again

News and commentary from the world of neurology and neuroscience

California , United-states , Judy-george , Reuters , Clinical-medicine , Event-reporting-system , Therapeutic-advances , Cellstem-cell , Storm-cell-therapeutics , Neurology-clinical-practice , Wall-street-journal , Medpage-today

Unpacking Averages: Adverse Events for Device-Lead Combination Products | Epstein Becker & Green

Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines.  If we were, for example, to focus on drugs alone with...

Epstein-becker , Postmarket-safety-reporting , Combination-products , Event-reporting-system , Quarterly-data-extract-files , Device-led-combination ,

Adverse Events for Device-Lead Combination Products

Adverse Events for Device-Lead Combination Products
natlawreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from natlawreview.com Daily Mail and Mail on Sunday newspapers.

Postmarket-safety-reporting , Combination-products , Event-reporting-system , Quarterly-data-extract-files , Device-led-combination ,

Investigation reveals FDA raised flags about continued Paragard IUD breaks in 2022

Investigation reveals FDA raised flags about continued Paragard IUD breaks in 2022
fox17.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fox17.com Daily Mail and Mail on Sunday newspapers.

Washington , United-states , America-angie-moreschi , Jennifer-davis , Coopersurgical-paragard , Human-services , Drug-administration , Department-of-health , Angie-moreschi , Event-reporting-system , North-tonawanda , Information-act

Investigation reveals FDA raised flags about continued Paragard IUD breaks in 2022

Investigation reveals FDA raised flags about continued Paragard IUD breaks in 2022
kimatv.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from kimatv.com Daily Mail and Mail on Sunday newspapers.

Washington , United-states , Coopersurgical-paragard , America-angie-moreschi , Jennifer-davis , Human-services , Drug-administration , Department-of-health , Angie-moreschi , Event-reporting-system , North-tonawanda , Information-act

Electronic Submission of Expedited Safety Reports

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry

Drug-administration , Guidance-issuing-office , Docket-number , Drug-evaluation , Event-reporting-system ,