Exclusive

Publication

Byline

Location

Singapore Clinical Trial: Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, Preceded by a Single Ascending Dose Portion and a Phase 2 Open-Label Portion, to Evaluate the Safety and Efficacy of Oral Infigratinib in Infants and Young Children with Achondroplasia

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, Preceded by a Single Ascend... Read More


Singapore Clinical Trial: A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant ... Read More


Singapore Clinical Trial: A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway... Read More


Singapore Clinical Trial: CA088-1007: A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'CA088-1007: A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safet... Read More


Singapore Clinical Trial: A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium-177 (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care Versus Standard of Care Alone in Patients with Prostate-Specific Membrane Antigen (PSMA) Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) after Androgen Receptor Pathway Inhibitor (ARPI) Treatment

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lu... Read More


Singapore Clinical Trial: CO45042: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib Plus Pembrolizumab Versus Pembrolizumab And Pemetrexed And Carboplatin or Cisplatin in Patients with Previously Untreated, KRAS G12C-Mutated, Advanced Or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'CO45042: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib... Read More


Singapore Clinical Trial: A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Placebo-Controlled Phase 3 Followed by an Open-Label Extension to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Radiprodil in Participants With GRIN-Related Neurodevelopmental Disorder

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Pla... Read More


Singapore Clinical Trial: A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients with Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX-3)

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solut... Read More


Singapore Clinical Trial: RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib M... Read More


Singapore Clinical Trial: A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

Singapore, June 16 -- The Health Sciences Authority received information related to the study titled 'A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembr... Read More