NMPA/PMDA-regulated pharmaceutical news, drug approvals, and clinical trial updates for the Asia-Pacific market.https://novapharmanews.com/enMon, 04 May 2026 22:25:03 GMThttps://novapharmanews.com/apac/news/xtalpi-pep08-prmt5-inhibitor-phase-1-cancer-trial-enrollment/https://novapharmanews.com/apac/news/xtalpi-pep08-prmt5-inhibitor-phase-1-cancer-trial-enrollment/XtalPi and PharmaEngine's AI-discovered PRMT5 inhibitor PEP08 starts Phase I solid tumor trial, marking major milestone in synthetic lethality cancer treatment.Mon, 04 May 2026 21:17:29 GMTnewsKenji Watanabehttps://novapharmanews.com/apac/news/spontan-phase-ii-data-10-minute-onset-fda-requirements-erectile-dysfunction/https://novapharmanews.com/apac/news/spontan-phase-ii-data-10-minute-onset-fda-requirements-erectile-dysfunction/SPONTAN Phase II interim results demonstrate 10-minute median onset versus 60 minutes for oral vardenafil, meeting FDA pharmacokinetic requirements.Mon, 04 May 2026 21:17:19 GMTnewsDr. Grace Tanhttps://novapharmanews.com/apac/news/ironwood-pharmaceuticals-short-bowel-syndrome-tpn-survey-ddw-2026/https://novapharmanews.com/apac/news/ironwood-pharmaceuticals-short-bowel-syndrome-tpn-survey-ddw-2026/Ironwood Pharmaceuticals presents DDW 2026 survey findings highlighting unmet needs in total parenteral nutrition therapy for short bowel syndrome patients.Mon, 04 May 2026 21:16:57 GMTnewsHiroshi Satohttps://novapharmanews.com/apac/news/edwards-lifesciences-resilia-tissue-10-year-commence-trial-results/https://novapharmanews.com/apac/news/edwards-lifesciences-resilia-tissue-10-year-commence-trial-results/Edwards Lifesciences announces 10-year COMMENCE trial data demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.Mon, 04 May 2026 21:16:22 GMTnewsHiroshi Satohttps://novapharmanews.com/apac/news/novo-nordisk-wegovy-china-launch-eli-lilly-obesity-market/https://novapharmanews.com/apac/news/novo-nordisk-wegovy-china-launch-eli-lilly-obesity-market/Novo Nordisk secures first-mover advantage launching Wegovy in China ahead of Eli Lilly's competing obesity drug, targeting massive untapped market opportunity.Mon, 04 May 2026 21:16:20 GMTnewsObesity/Weight ManagementArjun Menonhttps://novapharmanews.com/apac/news/arrowhead-pharmaceuticals-tga-approval-redemplo-plozasiran-australia-fcs/https://novapharmanews.com/apac/news/arrowhead-pharmaceuticals-tga-approval-redemplo-plozasiran-australia-fcs/Arrowhead Pharmaceuticals gains Australian TGA approval for REDEMPLO (plozasiran), expanding global access for familial chylomicronemia syndrome patients.Mon, 04 May 2026 21:15:28 GMTnewsDr. Priya Sharmahttps://novapharmanews.com/apac/news/biomarin-palynziq-fda-approval-adolescent-pku-patients/https://novapharmanews.com/apac/news/biomarin-palynziq-fda-approval-adolescent-pku-patients/BioMarin announces FDA approval of PALYNZIQ for adolescents 12+ with phenylketonuria (PKU), expanding treatment options for rare genetic disorder patients.Mon, 04 May 2026 21:15:04 GMTnewsDr. Mei Linhttps://novapharmanews.com/apac/news/rois-us-expansion-global-cdmo-fda-approval-injectable-manufacturing/https://novapharmanews.com/apac/news/rois-us-expansion-global-cdmo-fda-approval-injectable-manufacturing/ROIS establishes US operations as global CDMO with FDA, EMA, and other major regulatory approvals for end-to-end injectable drug manufacturing services.Mon, 04 May 2026 21:14:55 GMTnewsArjun Menonhttps://novapharmanews.com/apac/news/fda-approves-travere-filspari-fsgs-treatment-adults-children/https://novapharmanews.com/apac/news/fda-approves-travere-filspari-fsgs-treatment-adults-children/Travere Therapeutics receives FDA approval for FILSPARI to reduce proteinuria in FSGS patients aged 8 and older, expanding rare kidney disease treatment options.Mon, 04 May 2026 21:14:09 GMTnewsIsabella Cruzhttps://novapharmanews.com/apac/news/fda-approves-auvelity-new-mdd-treatment/https://novapharmanews.com/apac/news/fda-approves-auvelity-new-mdd-treatment/The FDA has approved Auvelity, a new oral antidepressant combining bupropion and dextromethorphan, for the treatment of major depressive disorder (MDD) in adults. Manufactured by Axsome Therapeutics, this approval marks a significant advancement in MDD treatment options.Mon, 04 May 2026 07:08:39 GMTnewsMajor Depressive Disorder (MDD)Dr. Hannah O'Connorhttps://novapharmanews.com/apac/news/sun-pharma-organon-partnership-india/https://novapharmanews.com/apac/news/sun-pharma-organon-partnership-india/Sun Pharma has announced a strategic partnership with Organon to commercialize five of Organon's established products across India. This collaboration aims to leverage Sun Pharma's extensive network to improve patient access to vital treatments.Mon, 04 May 2026 07:08:09 GMTnewswomen's health, spasticity, rheumatoid arthritisDr. Yuna Parkhttps://novapharmanews.com/apac/news/ucb-acquires-candid-therapeutics-2-2-billion-t-cell-engager-autoimmune/https://novapharmanews.com/apac/news/ucb-acquires-candid-therapeutics-2-2-billion-t-cell-engager-autoimmune/UCB's $2.2B acquisition of Candid Therapeutics brings novel T-cell engager technology for autoimmune diseases, marking major expansion beyond oncology applications.Mon, 04 May 2026 03:03:42 GMTnewsAutoimmune and inflammatory diseasesKenji Watanabehttps://novapharmanews.com/apac/articles/reckitt-benckiser-layoffs-new-jersey-mucinex/https://novapharmanews.com/apac/articles/reckitt-benckiser-layoffs-new-jersey-mucinex/Reckitt Benckiser, the company behind Mucinex, has announced further layoffs in New Jersey. This move signals ongoing restructuring within the pharmaceutical giant and reflects broader industry trends.Sun, 03 May 2026 07:08:33 GMTanalysisHiroshi Satohttps://novapharmanews.com/apac/news/fda-approves-auvelity-mdd-new-antidepressant/https://novapharmanews.com/apac/news/fda-approves-auvelity-mdd-new-antidepressant/The FDA has granted approval for Auvelity, a new oral medication for major depressive disorder (MDD) in adults. This approval introduces a novel treatment option with a distinct mechanism of action and a reported rapid onset of therapeutic effect.Sun, 03 May 2026 07:07:55 GMTnewsMajor Depressive DisorderMatteo Riccihttps://novapharmanews.com/apac/news/a2-milk-company-recalls-platinum-infant-formula-health-risk/https://novapharmanews.com/apac/news/a2-milk-company-recalls-platinum-infant-formula-health-risk/a2 Milk Company voluntarily recalls three batches of a2 Platinum Premium USA infant formula for 0-12 months due to potential health risks to babies.Sun, 03 May 2026 03:04:15 GMTnewsInfant NutritionDr. Mei Linhttps://novapharmanews.com/apac/articles/reckitt-benckiser-layoffs-mucinex-nj/https://novapharmanews.com/apac/articles/reckitt-benckiser-layoffs-mucinex-nj/Reckitt Benckiser, the company behind Mucinex, has announced further layoffs in New Jersey. This move signals ongoing strategic adjustments within the pharmaceutical giant.Sun, 03 May 2026 01:11:26 GMTanalysisHiroshi Satohttps://novapharmanews.com/apac/articles/auvelity-fda-approval-mdd-treatment/https://novapharmanews.com/apac/articles/auvelity-fda-approval-mdd-treatment/The FDA has approved Auvelity, a new oral antidepressant from Axsome Therapeutics, offering a novel mechanism of action for adults with major depressive disorder (MDD). This landmark approval signifies a significant advancement in depression treatment options.Sun, 03 May 2026 01:11:20 GMTanalysisMajor Depressive DisorderDr. Mei Linhttps://novapharmanews.com/apac/articles/nmpa-clinical-trial-regulations-impact-multinational-pharma-2024/https://novapharmanews.com/apac/articles/nmpa-clinical-trial-regulations-impact-multinational-pharma-2024/This article delves into the NMPA clinical trial regulations and their significant impact on multinational pharmaceutical data management and inspection processes.Sat, 02 May 2026 16:34:56 GMTanalysisDr. Laura Bennetthttps://novapharmanews.com/apac/articles/pmda-sakigake-accelerated-approval-bispecific-antibodies-leukemia-2026/https://novapharmanews.com/apac/articles/pmda-sakigake-accelerated-approval-bispecific-antibodies-leukemia-2026/This article delves into the SAKIGAKE Designation in Japan for bispecific antibodies, focusing on their potential to transform leukemia treatment by 2026.Sat, 02 May 2026 16:34:45 GMTanalysisoncologyleukemiaDr. Mei Linhttps://novapharmanews.com/apac/articles/pmda-guideline-updates-adaptive-trial-designs-data-transparency-2024/https://novapharmanews.com/apac/articles/pmda-guideline-updates-adaptive-trial-designs-data-transparency-2024/This article delves into the recent PMDA guideline updates and their implications for adaptive trial designs and data transparency in drug development.Sat, 02 May 2026 16:31:19 GMTanalysisClinical TrialsRegulatory AffairsDr. Emily Carterhttps://novapharmanews.com/apac/articles/cdsco-pmda-tga-harmonization-clinical-trial-regulations-2026/https://novapharmanews.com/apac/articles/cdsco-pmda-tga-harmonization-clinical-trial-regulations-2026/This article compares the clinical trial regulations of PMDA, TGA, and CDSCO, focusing on their impact on drug development and patient safety.Sat, 02 May 2026 16:31:08 GMTanalysisDr. Natalie Hugheshttps://novapharmanews.com/apac/articles/nmpa-conditional-approval-pathway-analysis-2024/https://novapharmanews.com/apac/articles/nmpa-conditional-approval-pathway-analysis-2024/Learn about China's NMPA Conditional Approval process, designed to expedite access to critical medications like XYZ for cancer patients.Sat, 02 May 2026 16:30:21 GMTanalysisoncologyrare diseasesArjun Menonhttps://novapharmanews.com/apac/news/fda-approves-auvelity-axsome-therapeutics-mdd/https://novapharmanews.com/apac/news/fda-approves-auvelity-axsome-therapeutics-mdd/The FDA has approved Auvelity (dextromethorphan and bupropion) from Axsome Therapeutics for the treatment of major depressive disorder (MDD) in adults. This marks a significant advancement in MDD therapy with a new mechanism of action.Sat, 02 May 2026 07:08:29 GMTnewsMajor Depressive DisorderSofia Alvarezhttps://novapharmanews.com/apac/news/vector-science-therapeutics-microneedle-catheter-patent-intratumoral-drug-delivery/https://novapharmanews.com/apac/news/vector-science-therapeutics-microneedle-catheter-patent-intratumoral-drug-delivery/Vector Science & Therapeutics secures IP protection for novel microneedle catheter technology designed to deliver cancer drugs directly into tumors.Sat, 02 May 2026 03:11:05 GMTnewsDr. Mei Linhttps://novapharmanews.com/apac/news/apotex-generic-ozempic-semaglutide-health-canada-approval-2026/https://novapharmanews.com/apac/news/apotex-generic-ozempic-semaglutide-health-canada-approval-2026/Apotex becomes first Canadian pharmaceutical company to receive Health Canada approval for Apo-Semaglutide Injection, a generic equivalent of Ozempic.Sat, 02 May 2026 03:10:38 GMTnewsDr. Yuna Parkhttps://novapharmanews.com/apac/news/keenova-terlivaz-terlipressin-clinical-data-digestive-disease-week-2026/https://novapharmanews.com/apac/news/keenova-terlivaz-terlipressin-clinical-data-digestive-disease-week-2026/Keenova Therapeutics shares new TERLIVAZ (terlipressin) clinical analysis for hepatorenal syndrome-acute kidney injury at DDW 2026, expanding treatment evidence.Sat, 02 May 2026 03:10:02 GMTnewsDr. Grace Tanhttps://novapharmanews.com/apac/news/kodiak-sciences-ksi-101-clinical-data-macular-edema-conferences/https://novapharmanews.com/apac/news/kodiak-sciences-ksi-101-clinical-data-macular-edema-conferences/Kodiak Sciences will present KSI-101 clinical data for macular edema secondary to inflammation, with Phase 3 results expected in Q4 2026.Sat, 02 May 2026 03:09:33 GMTnewsArjun Menonhttps://novapharmanews.com/apac/news/plozasiran-tga-approval-australia-redemplo-fcs/https://novapharmanews.com/apac/news/plozasiran-tga-approval-australia-redemplo-fcs/Arrowhead Pharmaceuticals announced the TGA approval of REDEMPLO® (plozasiran) in Australia for the treatment of Familial Chylomicronemia Syndrome (FCS). This significant milestone expands global access to a novel therapy for patients with this rare genetic disorder.Sat, 02 May 2026 01:11:35 GMTnewsFamilial Chylomicronemia Syndrome (FCS)Dr. Laura Bennetthttps://novapharmanews.com/apac/articles/purdue-pharma-shutdown-oxycontin-settlement/https://novapharmanews.com/apac/articles/purdue-pharma-shutdown-oxycontin-settlement/Purdue Pharma, the manufacturer of OxyContin, is ceasing operations as part of a $7.4 billion settlement to resolve claims related to the opioid crisis. This landmark deal signifies a major turning point in the legal and societal reckoning with the epidemic.Sat, 02 May 2026 01:11:04 GMTanalysisPainDr. Yuki Tanakahttps://novapharmanews.com/apac/news/namsa-lexitas-partnership-ophthalmic-medical-device-development/https://novapharmanews.com/apac/news/namsa-lexitas-partnership-ophthalmic-medical-device-development/NAMSA partners with Lexitas Pharma Services to offer end-to-end ophthalmic medical device development, creating single-source solution for sponsors.Fri, 01 May 2026 03:23:18 GMTnewsKenji Watanabehttps://novapharmanews.com/apac/news/verified-clinical-trials-chubb-partnership-patient-safety-data-quality/https://novapharmanews.com/apac/news/verified-clinical-trials-chubb-partnership-patient-safety-data-quality/Verified Clinical Trials and Chubb announce strategic alliance to improve clinical trial participant safety, data quality, and study integrity worldwide.Fri, 01 May 2026 03:21:58 GMTnewsDr. Grace Tanhttps://novapharmanews.com/apac/news/huahui-health-beone-medicines-hh160-trispecific-antibody-oncology-partnership/https://novapharmanews.com/apac/news/huahui-health-beone-medicines-hh160-trispecific-antibody-oncology-partnership/Huahui Health grants BeOne Medicines exclusive worldwide rights to develop HH160, a novel trispecific antibody for cancer immunotherapy treatment.Fri, 01 May 2026 03:21:22 GMTnewsHiroshi Satohttps://novapharmanews.com/apac/news/amgen-q1-2026-financial-results-double-digit-growth/https://novapharmanews.com/apac/news/amgen-q1-2026-financial-results-double-digit-growth/Amgen's Q1 2026 results show robust performance with 16 brands posting double-digit growth, offsetting patent expirations and increased competition.Fri, 01 May 2026 03:21:03 GMTnewsDr. Priya Sharmahttps://novapharmanews.com/apac/news/haier-biomedical-international-revenue-growth-2025/https://novapharmanews.com/apac/news/haier-biomedical-international-revenue-growth-2025/Haier Biomedical achieves 36% international revenue share with $340.77M total revenue, driving AI-powered life science infrastructure expansion globally.Fri, 01 May 2026 03:20:34 GMTnewsDr. Priya Sharmahttps://novapharmanews.com/apac/news/tga-combination-boundary-products-guidance-apac-pharmaceutical/https://novapharmanews.com/apac/news/tga-combination-boundary-products-guidance-apac-pharmaceutical/Australia's TGA provides regulatory clarity on combination products like pre-filled syringes and boundary products including nasal decongestants.Fri, 01 May 2026 03:19:38 GMTnewsDr. Yuki Tanakahttps://novapharmanews.com/apac/news/genprex-israel-patent-reqorsa-gene-therapy-pd1-antibodies-cancer/https://novapharmanews.com/apac/news/genprex-israel-patent-reqorsa-gene-therapy-pd1-antibodies-cancer/Genprex secures Israeli patent protection for Reqorsa gene therapy combination with PD-1 antibodies, strengthening intellectual property portfolio for cancer treatment.Fri, 01 May 2026 03:17:00 GMTnewsDr. Grace Tanhttps://novapharmanews.com/apac/news/prolacta-human-milk-fortifiers-prescription-drug-status-japan-jasmine-trial/https://novapharmanews.com/apac/news/prolacta-human-milk-fortifiers-prescription-drug-status-japan-jasmine-trial/Prolacta achieves global regulatory milestone as Japan grants prescription drug status to human milk-based fortifiers for premature infants based on JASMINE trial data.Fri, 01 May 2026 03:16:47 GMTnewsNeonatal Care/Medical NutritionDr. Priya Sharmahttps://novapharmanews.com/apac/articles/nmpa-accelerated-approval-pathway-innovative-drug-market-entry-2024/https://novapharmanews.com/apac/articles/nmpa-accelerated-approval-pathway-innovative-drug-market-entry-2024/The NMPA Accelerated Approval Pathway significantly enhances the speed of innovative drug market entry in China, particularly for critical cancer treatments.Fri, 01 May 2026 02:10:11 GMTanalysisInnovative DrugsOncologyRare DiseasesDr. Yuna Parkhttps://novapharmanews.com/apac/articles/nmpa-approval-pd1-pdl1-lung-cancer-immunotherapy-2025/https://novapharmanews.com/apac/articles/nmpa-approval-pd1-pdl1-lung-cancer-immunotherapy-2025/This article delves into the NMPA's approval landscape for lung cancer immunotherapy, highlighting the emerging trends of PD-1/PD-L1 combination therapies by 2025.Fri, 01 May 2026 02:03:59 GMTanalysislung cancerimmunotherapyMatteo Riccihttps://novapharmanews.com/apac/articles/nmpa-conditional-approval-pathway-oncology-access-2024/https://novapharmanews.com/apac/articles/nmpa-conditional-approval-pathway-oncology-access-2024/The NMPA Conditional Approval Pathway significantly enhances access to innovative oncology drugs, facilitating timely treatment options for cancer patients.Fri, 01 May 2026 01:51:25 GMTanalysisOncologyDr. Lukas Schneiderhttps://novapharmanews.com/apac/articles/ama-implementation-regulatory-harmonization-pharmaceutical-market-access-2026/https://novapharmanews.com/apac/articles/ama-implementation-regulatory-harmonization-pharmaceutical-market-access-2026/The African Medicines Agency is set to revolutionize regulatory processes, ensuring faster market access for vital medicines across the continent.Thu, 30 Apr 2026 09:02:43 GMTanalysisMatteo Riccihttps://novapharmanews.com/apac/news/axoft-55m-series-a-brain-computer-interface-clinical-trials/https://novapharmanews.com/apac/news/axoft-55m-series-a-brain-computer-interface-clinical-trials/Axoft secures $55M Series A funding led by C.P. Group Innovation to advance bio-inspired brain-computer interface technology into global clinical trials.Thu, 30 Apr 2026 03:08:56 GMTnewsNeurotechnology/Brain-Computer InterfaceIsabella Cruzhttps://novapharmanews.com/apac/news/vivacta-bio-50-million-series-a-funding-gt801-car-t-therapy/https://novapharmanews.com/apac/news/vivacta-bio-50-million-series-a-funding-gt801-car-t-therapy/Vivacta Biotechnology closes $50M+ Series A funding to advance GT801, an innovative in vivo CAR-T therapy for blood cancers and autoimmune diseases.Thu, 30 Apr 2026 03:08:24 GMTnewsDr. Priya Sharmahttps://novapharmanews.com/apac/news/taimei-technology-ai-clinical-trials-biokorea-2026/https://novapharmanews.com/apac/news/taimei-technology-ai-clinical-trials-biokorea-2026/Taimei Technology showcases AI-driven drug development platform at BioKorea 2026, planning Korea market entry with advanced clinical research solutions.Thu, 30 Apr 2026 03:08:04 GMTnewsKenji Watanabehttps://novapharmanews.com/apac/news/energenesis-energi-f703dfu-diabetic-foot-ulcer-ewma-2026/https://novapharmanews.com/apac/news/energenesis-energi-f703dfu-diabetic-foot-ulcer-ewma-2026/Energenesis Biomedical will present clinical data for ENERGI-F703DFU gel, a novel topical treatment for diabetic foot ulcers, at EWMA 2026 in Bremen.Thu, 30 Apr 2026 03:07:55 GMTnewsDr. Priya Sharmahttps://novapharmanews.com/apac/news/ascletis-pharma-diabetes-drug-data-ada-2026-scientific-sessions/https://novapharmanews.com/apac/news/ascletis-pharma-diabetes-drug-data-ada-2026-scientific-sessions/Ascletis Pharma will present clinical data on multiple diabetes programs at the ADA 2026 Scientific Sessions, showcasing pipeline developments in diabetes treatment.Thu, 30 Apr 2026 03:07:16 GMTnewsHiroshi Satohttps://novapharmanews.com/apac/news/tlx597-tx-psma-radioligand-therapy-optimal-trial-prostate-cancer/https://novapharmanews.com/apac/news/tlx597-tx-psma-radioligand-therapy-optimal-trial-prostate-cancer/TLX597-Tx radioligand therapy demonstrates low organ toxicity in OPTIMAL-PSMA trial, potentially enabling dose intensification for prostate cancer treatment.Thu, 30 Apr 2026 03:06:53 GMTnewsDr. Grace Tanhttps://novapharmanews.com/apac/news/immunitybio-securities-fraud-lawsuit-anktiva-fda-warning-letter/https://novapharmanews.com/apac/news/immunitybio-securities-fraud-lawsuit-anktiva-fda-warning-letter/ImmunityBio hit with class action lawsuit after FDA determined company made false claims about Anktiva bladder cancer drug's capabilities beyond approved use.Thu, 30 Apr 2026 03:06:24 GMTnewsOncology - Bladder CancerDr. Mei Linhttps://novapharmanews.com/apac/articles/nmepa-priority-review-pathway-innovative-drug-approvals-2024/https://novapharmanews.com/apac/articles/nmepa-priority-review-pathway-innovative-drug-approvals-2024/The NMPA Priority Review Pathway accelerates the approval of innovative drugs in China, significantly benefiting patients with critical health needs.Thu, 30 Apr 2026 02:09:23 GMTanalysisOncologyKenji Watanabehttps://novapharmanews.com/apac/articles/pmda-sakigake-designation-innovative-therapies-2024/https://novapharmanews.com/apac/articles/pmda-sakigake-designation-innovative-therapies-2024/The PMDA SAKIGAKE Designation fast-tracks innovative therapies, such as XYZ Drug for cancer, enhancing patient access to groundbreaking treatments in Japan.Thu, 30 Apr 2026 01:59:25 GMTanalysisOncologyRare DiseasesNeurologyInfectious DiseasesHiroshi Sato