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Development of T-cell lymphoma a 'serious' issue, 'very rare after CAR T-cell therapy'

Development of T-cell lymphoma a 'serious' issue, 'very rare after CAR T-cell therapy'
healio.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healio.com Daily Mail and Mail on Sunday newspapers.

San-antonio , Texas , United-states , Mindy-valcarcel , Byjosh-friedman , Guido-ghilardi , Peter-marks , University-of-pennsylvania-school-medicine , Tandem-meetings , Cellular-therapy-meetings , Biologic-evaluation , Nature-medicine

FDA official says CAR-T 'incredibly beneficial' despite secondary malignancy risk

FDA official says CAR-T 'incredibly beneficial' despite secondary malignancy risk
healio.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healio.com Daily Mail and Mail on Sunday newspapers.

Washington , United-states , Peter-marks , Mindy-valcarcel , Byjosh-friedman , Bristol-myers-squibb , Kite-pharma-gilead-sciences , Novartis , Alliance-for-regenerative-medicine , Biologic-evaluation , Regenerative-medicine , Legend-biotech

RSV Vaccine Approved For Older Adults By FDA

(CTN News) - Wednesday, the FDA approved the RSV vaccine from drugmaker GSK to protect seniors against the virus that causes.........

Chile , United-states , Chilean , Peter-marks , Michael-melgar , Centers-for-disease , National-institutes-of-health , Biologic-evaluation , Disease-control , National-institutes , Health ,

FDA limits use of Johnson and Johnson's Janssen COVID-19 vaccine

The FDA announced on Thursday it is limiting the use of the Janssen COVID-19 vaccine to people 18 or older after an investigation found that those who received the jab were at risk of blood clots.

United-states , Peter-marks , Drug-administration , Johnson , Biologic-evaluation , Emergency-use-authorization , Dailymail , News , Coronavirus , Breaking-news ,

FDA director says medical practice changed, loosening prescribing of opioid pills with more addicts

CHARLESTON – A director of the Food & Drug Administration says physicians in the 1990s lost their fear of prescribing opioids, leading to higher rates of addiction.

Florida , United-states , Kanawha , West-virginia , Washington , Peter-marks , Derek-swope , Patrick-morrisey , Courtroom-view-network , Boone-circuit-court , Judicial-district-kanawha-court , Kanawha-circuit-court

What is an Investigational New Drug?

The development of new, safe, and efficacious medications is subject to strict guidelines set out by international bodies and governments.

Investigational-new-drug-program , Drug-administration , Centers-for-biologic-evaluation , New-drug , Biologic-evaluation , Investigational , Rugs , Rug , Rial ,

New Rules for Drug-Device Combos | Locke Lord LLP

FDA recently issued its new final guidance concerning the appropriate pathway for review of drug-device combination products, Principles of Premarket Pathways for Combination Products...

Radiological-health , Locke-lord , Premarket-pathways , Combination-products-guidance , Primary-mode , Drug-evaluation , Biologic-evaluation , Combination-product , Federal-food , Cosmetic-act ,

PacBio's Precision Health Partnership, NVIDIA's Open Source SDK, More

PacBio's Precision Health Partnership, NVIDIA's Open Source SDK, More
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Australia , California , United-states , Burlington , Victoria , Barcelona , Comunidad-autonoma-de-cataluna , Spain , America , Arisglobal-lifesphere , Nanowizardv-bio , Youngmee-jee

ArisGlobal: The FDA Goes Live with LifeSphere MultiVigilance, Modernizing Pharmacovigilance Capabilities with FAERS II

ArisGlobal's industry leading pharmacovigilance platform automates the intake, triage, and processing of over three million safety reports per year, improving regulatory processes and data quality. MIAMI

China , Miami , Florida , United-states , Japan , India , Sankesh-abbhi , Arisglobal-lifesphere , Prnewswire-arisglobal , Kostenloser-wertpapierhandel , Lifesphere-multivigilance , United-states-department-of-health