Tag: FDA

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors
April 3, 2022 Off

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

By Author

Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors.

Kite’s Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)
April 2, 2022 Off

Kite’s Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

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Kite, a Gilead Company (Nasdaq: GILD), has announced the U.S. Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

FDA warns about fraudulent COVID-19 test kits for home use
March 21, 2020 Off

FDA warns about fraudulent COVID-19 test kits for home use

By Dino Mustafić

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

FDA kicks off pilot program for recognizing qualified accreditation bodies who would accredit testing laboratories
September 21, 2019 Off

FDA kicks off pilot program for recognizing qualified accreditation bodies who would accredit testing laboratories

By Dino Mustafić

The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.