GlobeNewswire: Mesoblast Limited Contains the last 10 of 265 releaseshttp://www.globenewswire.com/External?Length=42024-03-28T21:02:56ZGlobeNewswirehttp://www.globenewswire.com/External?Length=4newsdesk@globenewswire.com (NewsDesk)https://www.globenewswire.com/news-release/2024/03/26/2852084/0/en/United-States-Food-Drug-Administration-FDA-Notifies-Mesoblast-that-Available-Clinical-Data-from-Phase-3-Trial-Appear-Sufficient-to-Support-BLA-Submission-for-Remestemcel-L-in-Child.html?f=22&fvtc=4&fvtv=27784United States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)2024-03-26T02:34:20Z<![CDATA[NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).]]>https://www.globenewswire.com/news-release/2024/03/13/2845924/0/en/Mesoblast-Successfully-Completes-Placement-and-Accelerated-Entitlement-Offer.html?f=22&fvtc=4&fvtv=27784Mesoblast Successfully Completes Placement and Accelerated Entitlement Offer2024-03-13T23:30:47Z<![CDATA[NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has received firm commitments to complete its pro-rata accelerated non-renounceable entitlement offer that was launched on 4 December, 2023 (Entitlement Offer). Together the entitlement offer and institutional placement raised gross proceeds of A$97 million, including A$36.7 million committed today on the same terms as the Entitlement Offer, primarily from Mesoblast’s existing major shareholders.]]>https://www.globenewswire.com/news-release/2024/03/10/2843446/0/en/United-States-Food-Drug-Administration-FDA-Supports-Accelerated-Approval-Pathway-for-Rexlemestrocel-L-in-End-Stage-Heart-Failure-Patients-with-a-Left-Ventricular-Assist-Device-LVAD.html?f=22&fvtc=4&fvtv=27784United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)2024-03-10T23:54:12Z<![CDATA[NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor®) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.]]>https://www.globenewswire.com/news-release/2024/02/28/2837527/0/en/Mesoblast-Reports-Financial-Results-and-Operational-Update-for-Half-Year-Ended-December-31-2023.html?f=22&fvtc=4&fvtv=27784Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 20232024-02-28T22:57:09Z<![CDATA[NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.]]>https://www.globenewswire.com/news-release/2024/02/26/2834984/0/en/Mesoblast-Financial-Results-and-Corporate-Update-Webcast.html?f=22&fvtc=4&fvtv=27784Mesoblast Financial Results and Corporate Update Webcast2024-02-26T12:00:00Z<![CDATA[NEW YORK, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the six months ended December 31, 2023.]]>https://www.globenewswire.com/news-release/2024/02/15/2829545/0/en/United-States-Food-Drug-Administration-FDA-Grants-Mesoblast-Orphan-Drug-Designation-for-Revascor-Rexlemestrocel-L-in-Children-With-Congenital-Heart-Disease.html?f=22&fvtc=4&fvtv=27784United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease2024-02-15T00:46:40Z<![CDATA[NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition. This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month.]]>https://www.globenewswire.com/news-release/2024/01/31/2820682/0/en/Appendix-4C-Quarterly-Activity-Report-for-Quarter-Ended-December-31-2023.html?f=22&fvtc=4&fvtv=27784Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 20232024-01-31T02:13:34Z<![CDATA[]]>https://www.globenewswire.com/news-release/2024/01/18/2812039/0/en/United-States-Food-Drug-Administration-FDA-Grants-Mesoblast-Rare-Pediatric-Disease-Designation-for-Revascor-Rexlemestrocel-L-in-Children-With-Congenital-Heart-Disease.html?f=22&fvtc=4&fvtv=27784United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease2024-01-18T23:36:00Z<![CDATA[REVASCOR Increases Size of Left Heart Chamber and Improves Surgical Outcomes in Children with Hypoplastic Left Heart Syndrome: Results Published in Journal of Thoracic and Cardiovascular Surgery Open]]>https://www.globenewswire.com/news-release/2023/11/26/2785808/0/en/Mesoblast-Files-for-Orphan-Drug-and-Pediatric-Rare-Disease-Designations-for-Rexlemestrocel-L-as-Treatment-for-Severe-Congenital-Heart-Disease.html?f=22&fvtc=4&fvtv=27784Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease2023-11-26T23:56:21Z<![CDATA[NEW YORK, Nov. 26, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has filed for orphan drug designation (ODD) and rare pediatric disease designation (RPDD) with the United States Food and Drug Administration (FDA) for its allogeneic cell therapy Revascor® (rexlemestrocel-L) in the treatment of the congenital heart disease hypoplastic left heart syndrome (HLHS). The filings were based on results from a blinded, randomized, controlled prospective trial of REVASCOR conducted at a single center in the US in 19 children with HLHS and accepted for publication in an upcoming issue of the peer reviewed The Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open).1]]>https://www.globenewswire.com/news-release/2023/11/21/2784503/0/en/Mesoblast-Partners-With-Blood-and-Marrow-Transplant-Clinical-Trials-Network-BMT-CTN-on-Pivotal-Trial-in-Adults-With-SR-aGVHD.html?f=22&fvtc=4&fvtv=27784Mesoblast Partners With Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on Pivotal Trial in Adults With SR-aGVHD2023-11-21T23:32:27Z<![CDATA[NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a body including centers responsible for approximately 80% of all US allogeneic BMTs, has entered into an agreement to develop a pivotal trial of Mesoblast’s lead product candidate Ryoncil® (remestemcel-L) in the treatment of adults with steroid-refractory acute graft versus host disease (SR-aGvHD). The BMT CTN is funded by the United States National Institutes of Health (NIH).]]>