Cellectar Announces FDA Grants Exemption to Import Alert for CLR 131 Hematology Studies
Cellectar Biosciences, Inc. (CLRB)
Last cellectar biosciences, inc. earnings: 11/12 08:00 am
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Source: GlobeNewswire
Clinical Trials to Advance Across Multiple Hematology Programs FLORHAM PARK, N.J., Nov. 12, 2018 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted an exemption to the Import Alert placed on the Centre for Probe Development and Commercialization (CPDC), the sole supplier of the CLR 131. The exemption for CLR 131 is effective immediately for all hematology studies and, in response, Cellectar is preparing to dose patients in the second fractionated dose cohort of the Phase 1 relapsed refractory (R/R) multiple myeloma study and the Phase 2 study for R/R hematologic malignancies. The company awaits authorization from the FDA for any future shipments in connection with its Phase 1 study of pediatric patients with neuroblastoma, sarcomas, lymphomas (including H
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CLRB
Sec Filings
- 4/25/24 - Form SC
- 4/1/24 - Form 10-K/A
- 3/27/24 - Form 8-K
- CLRB's page on the SEC website