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July 24, 2023
TEL AVIV - RedHill Biopharma Ltd. , a specialty biopharmaceutical company, today announced that opaganib[1] has been awarded a further $1.7 million in U.S. Government funding, via a Small Business...
July 21, 2023
Opaganib awarded a further $1.7 million in U.S. Government funding for development as a medical countermeasure for gastrointestinal acute radiation syndrome...
July 21, 2023
/PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered...
July 19, 2023
/PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today issues its Appendix 4C quarterly cash flow report and accompanying...
June 22, 2023
The FDA has issued a complete response letter to the new drug application seeking the approval of ADX-2191 for the treatment of patients with primary vitreoretinal lymphoma.
June 21, 2023
By Will Feuer Aldeyra Therapeutics said it has received a complete response letter from the U.S. Food and Drug Administration that said there was a lack of...
June 21, 2023
Biotechnology company Aldeyra Therapeutics, Inc. (ALDX) announced Wednesday the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).
June 21, 2023
Based on U.S. Food & Drug Administration (FDA) Determination of Lack of Adequate and Well Controlled Investigations in the Scientific Literature, Complete Response Letter Received for New Drug Application (NDA) of ADX-2191 (methotrexate injection, USP) for the Treatment of Primary Vitreoretinal Lymphoma (PVRL) Due to Shortage of Methotrexate, Lack of Approved Therapy for PVRL, and Inbound Requests for ADX-2191, Expanded Access Program Planned to be Discussed with FDA
June 12, 2023
Q1/23 Talicia net revenues of $3.4 million; Cash balance of $28.8 million as of March 31, 2023[1]; Extinguishment of all debt obligations in exchange for the...
June 5, 2023
Real-World Results Demonstrate Objective Response Rate of 67% in 24 EBV+ PTLD Patients 91% Overall Survival at One Year for Patients Responding to Tab-cel Compared to 34% for... | June 5, 2023