FDA Grants Exemption to Import Alert for Cellectar’s CLR 131 in Pediatric and Adolescent Patients
Cellectar Biosciences, Inc. (CLRB)
Last cellectar biosciences, inc. earnings: 11/12 08:00 am
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Source: GlobeNewswire
FLORHAM PARK, N.J., March 19, 2019 (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, today announced 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) for the use of CLR 131 in connection with the company’s pediatric IND. This exemption will allow Cellectar to immediately begin enrolling patients in its Phase 1 pediatric study for the treatment of select relapsed or refractory solid tumors including neuroblastoma, lymphomas and malignant brain tumors. Cellectar is already enrolling patients in its Phase 1 and Phase 2 multiple myeloma and select B-cell lymphoma studies of CLR 131 after having received FDA exemption to the CPDC Import Alert in November 2018 for its hematology IND. “We are grateful that the FDA has gr
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CLRB
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- CLRB's page on the SEC website