All News
FDA Approves First Oral Treatment for Postpartum Depression
Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.
Novo Holdings Increases Investment in Halodoc to Strengthen Indonesia’s Health System
Novo Holdings today announced that it has increased its investment in Halodoc, an Indonesia-based healthtech platform, by joining the US $135 million Series D funding round led by Astra International Tbk (Astra).
Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the US Food and Drug Administration (FDA) has provided a complete response to its Biologics License Application (BLA) resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) and requires more data to support marketing approval.
House committee quizzes BlackRock and MSCI on China investments
The US House of Representatives China committee has accused BlackRock and MSCI of profiting from investments that help the Chinese military and undermine American values and security.
Universe Pharmaceuticals INC Announces Receipt of Nasdaq Notification Regarding Minimum Market Value of Publicly Held Shares
Universe Pharmaceuticals INC (NASDAQ: UPC) (“Universe Pharmaceuticals” or the “Company”), a pharmaceutical producer and distributor in China, today announced that the Company received a written notification (the “Notification Letter”) from the Nasdaq Stock Market LLC (“Nasdaq”) on August 1, 2023, notifying the Company that it is not in compliance with the minimum Market Value of Publicly Held Shares (“MVPHS”) requirement set forth in the Nasdaq Listing Rules for continued listing on the Nasdaq Global Market.
Sosei Heptares Operational Highlights and Consolidated Results for the Second Quarter and First Half of 2023
Sosei Group Corporation (“the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the second quarter and first half ended 30 June 2023.
Burning Rock Provides Second Quarter 2023 Business Updates and Schedules Earnings Release on August 31, 2023
Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that it plans to release its unaudited financial results for the second quarter of 2023 before the U.S. market opens on August 31, 2023.
Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar | Organon
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira® (adalimumab). The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study (NCT05510063) for SB5 was conducted across 33 sites in four countries (Bulgaria, Czechia, Lithuania, Poland) from August 2022 to May 2023 in patients with moderate to severe chronic plaque psoriasis.
Mundipharma International Corporation Limited, Mundipharma Medical Company, and Acrotech Biopharma Inc. Enter Agreement to Transfer License of FOLOTYN® (Pralatrexate) in China to CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the execution of an Assignment Agreement (the "Agreement") with Mundipharma International Corporation Limited ("MICL"), Mundipharma Medical Company ("MMCo"), and Acrotech Biopharma Inc. ("Acrotech") for the commercialization of FOLOTYN® (Pralatrexate) in the People's Republic of China ("China").
U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation
ABM Therapeutics (ABM) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, a novel small molecule BRAF inhibitor developed by the company, for the treatment of patients with glioblastoma (GBM) bearing BRAF V600 mutation.
