US FDA mandates label updates on CAR-T cancer therapies [Reuters]
Novartis AG (NVS)
Last novartis ag earnings: 4/28 01:00 am
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Source: Reuters
so-called "boxed warning" to highlight the serious risk of T-cell blood cancer in patients who use these therapies. The health regulor has required related updates to other sections of the label such as warnings and precautions, postmarketing experience, patient counseling information and medication guide. The agency said patients and clinical trial participants receiving treatment with these products should be monitored life-long for secondary malignancies and the manufacturer should be notified in the event of a new malignancy. In January , the FDA asked a host of drugmakers including Gilead Sciences (GILD.O) New Tab , opens new tab , Johnson & Johnson (JNJ.N) New Tab , opens new tab and Novartis (NOVN.S) New Tab , opens new tab to add a boxed warning to their CAR-T cancer therapies, as it received reports of patients developing a type of T-cell blood cancer after being treated with them. The other cancer therapies include Bristol Myers Squibb's (BMY.N) New Tab , ope
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NVS
Earnings
- 4/23/24 - Beat
NVS
Sec Filings
- 4/23/24 - Form 6-K
- 2/15/24 - Form S-8
- 2/2/24 - Form SC
- NVS's page on the SEC website