Clinical & Regulatory
Lynk Pharmaceuticals Announced Positive Topline Data from Phase II Clinical Trial of LNK01001 in the Treatment of Atopic Dermatitis
HANGZHOU, China, Aug. 9, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced positive topline data from a Phase II clinical trial of LNK01001 for the treatment of atopic dermatitis.
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.
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.
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.
LianBio Announces First Patient Treated in Phase 1 Trial of SHP2 Inhibitor BBP-398 in Combination with Osimertinib in Patients with Non-Small Cell Lung Cancer with EGFR Mutations
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, an investigational SHP2 inhibitor, in combination with AstraZeneca’s osimertinib, an epidermal growth factor receptor (EGFR) inhibitor, for the treatment of patients with non-small cell lung cancer (NSCLC) with EGFR mutations.
Doer Biologics Announces First Subject Dosed in Phase I 12-Week Multiple-Ascending Dose (MAD) Clinical Trial of DR10624 and Received IND Approval From NMPA
Zhejiang Doer Biologics Co., Ltd. ("Doer Bio"), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers, today announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting Glucagon-like peptide-1 receptor (GLP-1R), Glucagon receptor (GCGR), and Fibroblast growth factor 21 receptor (FGF21R), has completed the dosing of the first subject in the Phase Ib 12-week Multiple-Ascending Dose (MAD) study of DR10624 for the treatment of obesity and hypertriglyceridemia in New Zealand.
NMPA and FDA Approved the First-in-Human Clinical Trial Applications to Evaluate LBL-034, An Anti-GPRC5D/CD3 Bispecific Antibody Developed by Leads Biolabs, in Relapsed/Refractory Multiple Myeloma
Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") announced today that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human Investigational New Drug (IND) applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody invented by Leads Biolabs with global intellectual property rights, for the treatment of relapsed/refractory multiple myeloma. Currently, no GPRC5D-targeting antibody has been approved for marketing.
Skincare Tech Brand AMIRO Receives QTL Certification from SGS to Strengthen R&D Efforts
AMIRO ("the Company"), a leading beauty and skincare technology brand, is thrilled to announce that its research facility, AMIRO LAB, has successfully obtained the Qualified Testing Location (QTL) certification after a comprehensive audit conducted by SGS.
Biosion Announces Phase II Study Start for Anti-TSLP mAb BSI-045B in Atopic Dermatitis (ADAMANT)
Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced the phase 2 study initiation for the evaluation of BSI-045B, an anti-TLSP mAb, in the treatment of atopic dermatitis (AD) .
Everest Medicines Announces Completion of Patient Enrollment in Nefecon® China Open Label Extension Study
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today the completion of patient enrollment for the China open-label extension (cOLE) of the Phase 3 NefIgArd study.
