Y-mAbs Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children.
Moderna has announced that it has received written confirmation from the European Medicines Agency (EMA) that mRNA-1273, the Company’s vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure.
Gannex Pharma, a wholly owned company of Ascletis Pharma announces that it received investigational new drug application (IND) approval from FDA for its drug candidate ASC42, to conduct clinical trials for non-alcoholic steatohepatitis (NASH) indication.
ARCA biopharma said that its investigational new drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalised with Covid-19 has been approved by the US Food and Drug Administration (FDA).
Oragenics, Inc. announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration (“FDA”) that it is in broad agreement with the Company’s planned approach to clinical development of its SARS-CoV-2 vaccine, Terra CoV-2.
Pfizer and BioNTech announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against Covid-19.
AstraZeneca has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for Farxiga (dapagliflozin) in chronic kidney disease (CKD) patients, with and without type 2 diabetes (T2D).
Baylx, a clinical-stage stem cell biopharmaceutical company focused on developing living stem cell products to address unmet medical needs, announced that the US Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with COVID-19.
Anokion SA, a Swiss biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for ANK-700, an antigen-specific drug candidate for the treatment of multiple sclerosis (MS).
Bristol Myers Squibb (BMS) and bluebird bio have secured priority review from the US Food and Drug Administration (FDA) for their co-developed investigational cell therapy idecabtagene vicleucel (ide-cel; bb2121) for the treatment of multiple myeloma.
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