Drugs Safety AlertFDA Revises Capecitabine and 5-FU Labels to Address DPD Deficiency Risk FDA Revises Capecitabine and 5-FU Labels to Address DPD Deficiency Risk Read Post »
Clinical TrailsFDA Grants Orphan Drug Designation to Zenocutuzumab for NRG1-Fusion Cholang... FDA Grants Orphan Drug Designation to Zenocutuzumab for NRG1-Fusion Cholang... Read Post »
Health TidingsNovo Nordisk Accuses Hims & Hers of Illegal Semaglutide Compounding, Ci... Novo Nordisk Accuses Hims & Hers of Illegal Semaglutide Compounding, Ci... Read Post »
Clinical TrailsBayer’s Asundexian Cuts Stroke Risk 26% in Phase III Bayer’s Asundexian Cuts Stroke Risk 26% in Phase III Read Post »
Health TidingsBMS and J&J Rethink Anticoagulation with Factor Xia BMS and J&J Rethink Anticoagulation with Factor Xia Read Post »
Health TidingsSimcere Doses First Patient in Anti-Stroke SIM0811 Trial Simcere Doses First Patient in Anti-Stroke SIM0811 Trial Read Post »
Food Policy & AcquisitionsNo to Artificial Colors, Yes to Natural Alternatives: What the New FDA Poli... No to Artificial Colors, Yes to Natural Alternatives: What the New FDA Poli... Read Post »
New Drug ApprovalFDA Approves VYBRIQUE as First Oral Film for Erectile Dysfunction FDA Approves VYBRIQUE as First Oral Film for Erectile Dysfunction Read Post »
New Drug ApprovalAbbVie Seeks FDA, EMA Approval of RINVOQ in Vitiligo AbbVie Seeks FDA, EMA Approval of RINVOQ in Vitiligo Read Post »
Health TidingsEli Lilly Q4 2025: Mounjaro and Zepbound Fuel 43% Growth Eli Lilly Q4 2025: Mounjaro and Zepbound Fuel 43% Growth Read Post »
Clinical TrailsUCB’s BIMZELX Achieves 3-Year HS Control: BE HEARD Trial Data Reveale... UCB’s BIMZELX Achieves 3-Year HS Control: BE HEARD Trial Data Reveale... Read Post »
Clinical TrailsFDA Fast Tracks Cumberland’s Ifetroban for DMD Heart Disease FDA Fast Tracks Cumberland’s Ifetroban for DMD Heart Disease Read Post »
Clinical TrailsAstellas Fezolinetant Cuts Menopausal VMS in Japan Phase 3 Astellas Fezolinetant Cuts Menopausal VMS in Japan Phase 3 Read Post »
Clinical TrailsImmunityBio Launches Phase 2 ResQ215B Trial for Indolent B-Cell Lymphoma ImmunityBio Launches Phase 2 ResQ215B Trial for Indolent B-Cell Lymphoma Read Post »
Health TidingsValneva and Butantan Start IXCHIQ Chikungunya Vaccination Pilot in Brazil Valneva and Butantan Start IXCHIQ Chikungunya Vaccination Pilot in Brazil Read Post »
ResearchJohnson & Johnson Calls Out Surgeon Mental Health Crisis Johnson & Johnson Calls Out Surgeon Mental Health Crisis Read Post »
Health TidingsNovo Nordisk Reports 10% Sales Growth in 2025 as Wegovy Pill Launch Strengt... Novo Nordisk Reports 10% Sales Growth in 2025 as Wegovy Pill Launch Strengt... Read Post »
Clinical TrailsNovo Nordisk’s CagriSema Outperforms Semaglutide in REIMAGINE 2 Trial Novo Nordisk’s CagriSema Outperforms Semaglutide in REIMAGINE 2 Trial Read Post »
Health TidingsSPARC’s Sezaby Approval Unlocks Rare Pediatric Priority Review Voucher SPARC’s Sezaby Approval Unlocks Rare Pediatric Priority Review Voucher Read Post »
New Drug ApprovalBayer’s Nubeqa Approved for mHSPC in China Bayer’s Nubeqa Approved for mHSPC in China Read Post »
Clinical TrailsPfizer Bets Big on Monthly GLP-1 After Metsera Deal, VESPER-3 Hits Key Endp... Pfizer Bets Big on Monthly GLP-1 After Metsera Deal, VESPER-3 Hits Key Endp... Read Post »
Health TidingsAstraZeneca Faces FDA Delay for At-Home Saphnelo SC in SLE AstraZeneca Faces FDA Delay for At-Home Saphnelo SC in SLE Read Post »
Clinical TrailsJohnson & Johnson Unveils Real-World Data: ERLEADA Cuts Death Risk by 5... Johnson & Johnson Unveils Real-World Data: ERLEADA Cuts Death Risk by 5... Read Post »
Health TidingsFDA Issues Complete Response Letter for Anaphylm Sublingual Epinephrine Fil... FDA Issues Complete Response Letter for Anaphylm Sublingual Epinephrine Fil... Read Post »
Clinical TrailsPositive Topline Results: Venglustat Succeeds in Sanofi’s LEAP2MONO GD3 S... Positive Topline Results: Venglustat Succeeds in Sanofi’s LEAP2MONO GD3 S... Read Post »
Policy & AcquisitionsIllumina Completes Acquisition of SomaLogic Illumina Completes Acquisition of SomaLogic Read Post »
New Drug ApprovalImfinzi Boosts Survival in Gastric Cancer, Gains CHMP Endorsement Imfinzi Boosts Survival in Gastric Cancer, Gains CHMP Endorsement Read Post »
Clinical TrailsLundbeck INFUSE Study: Vyepti Shines for Hard-to-Treat Migraine Lundbeck INFUSE Study: Vyepti Shines for Hard-to-Treat Migraine Read Post »
Health TidingsFDA Issues CRL for Pharming’s Joenja in Pediatric APDS Patients FDA Issues CRL for Pharming’s Joenja in Pediatric APDS Patients Read Post »
New Drug ApprovalCHMP Backs Rezurock for Chronic GVHD After Re-Examination CHMP Backs Rezurock for Chronic GVHD After Re-Examination Read Post »
New Drug ApprovalIncyte’s Zynyz Wins Positive CHMP Opinion in Advanced Anal Cancer Incyte’s Zynyz Wins Positive CHMP Opinion in Advanced Anal Cancer Read Post »
ResearchMigraine Attacks Disrupt Relationships, AbbVie Report Migraine Attacks Disrupt Relationships, AbbVie Report Read Post »
New Drug ApprovalEMA CHMP Recommends Bayer’s Finerenone for Heart Failure with LVEF â‰... EMA CHMP Recommends Bayer’s Finerenone for Heart Failure with LVEF â‰... Read Post »
New Drug ApprovalJ&J Scores CHMP Nod for AKEEGA in High-Risk Prostate Cancer J&J Scores CHMP Nod for AKEEGA in High-Risk Prostate Cancer Read Post »
New Drug ApprovalFDA Approves Tenpoint’s YUVEZZI Eye Drop for Presbyopia Treatment FDA Approves Tenpoint’s YUVEZZI Eye Drop for Presbyopia Treatment Read Post »
Clinical TrailsUltragenyx Resubmits BLA for UX111 Gene Therapy in Sanfilippo Syndrome Type... Ultragenyx Resubmits BLA for UX111 Gene Therapy in Sanfilippo Syndrome Type... Read Post »
Clinical TrailsTanabe Pharma’s ZYNLONTA® Hits Key Endpoint in Japanese r/r DLBCL Tr... Tanabe Pharma’s ZYNLONTA® Hits Key Endpoint in Japanese r/r DLBCL Tr... Read Post »
Policy & AcquisitionsAstraZeneca Bets Big on Next-Gen Obesity Drugs With CSPC AstraZeneca Bets Big on Next-Gen Obesity Drugs With CSPC Read Post »
Policy & AcquisitionsModerna Partners with Recordati to Advance mRNA-3927 for Propionic Acidemia Moderna Partners with Recordati to Advance mRNA-3927 for Propionic Acidemia Read Post »
Clinical TrailsFDA Grants Class II Review for Unicycive’s Resubmission of OLC in Hyperph... FDA Grants Class II Review for Unicycive’s Resubmission of OLC in Hyperph... Read Post »
Drugs Safety AlertFDA Halts REGENXBIO’s RGX-111 and RGX-121 After CNS Tumor Case FDA Halts REGENXBIO’s RGX-111 and RGX-121 After CNS Tumor Case Read Post »
Policy & AcquisitionsUS Officially Exits WHO in January 2026: Funding Cuts, COVID Fallout, and G... US Officially Exits WHO in January 2026: Funding Cuts, COVID Fallout, and G... Read Post »
Policy & AcquisitionsAstraZeneca Commits $15 Billion to China Expansion by 2030, Boosting Cell T... AstraZeneca Commits $15 Billion to China Expansion by 2030, Boosting Cell T... Read Post »
Clinical TrailsChugai Files Tecentriq for MRD-Positive Bladder Cancer in Japan Chugai Files Tecentriq for MRD-Positive Bladder Cancer in Japan Read Post »
Clinical TrailsBiogen’s Litifilimab Wins FDA Breakthrough Therapy Designation for Cutane... Biogen’s Litifilimab Wins FDA Breakthrough Therapy Designation for Cutane... Read Post »
Policy & AcquisitionsSeamless Therapeutics and Eli Lilly Partner to Advance Programmable Gene Ed... Seamless Therapeutics and Eli Lilly Partner to Advance Programmable Gene Ed... Read Post »
Clinical TrailsFDA Grants Priority Review to Otsuka’s Centanafadine NDA for ADHD Across ... FDA Grants Priority Review to Otsuka’s Centanafadine NDA for ADHD Across ... Read Post »
Policy & AcquisitionsSimcere Signs EUR 1.058B IBD Deal with Boehringer Ingelheim for SIM0709 Simcere Signs EUR 1.058B IBD Deal with Boehringer Ingelheim for SIM0709 Read Post »
New Drug ApprovalFDA Approves JnJ’s DARZALEX FASPRO Quadruplet for NDMM FDA Approves JnJ’s DARZALEX FASPRO Quadruplet for NDMM Read Post »
Clinical TrailsELEVIDYS Delivers 3-Year Sustained Motor Benefits in Ambulatory Duchenne Pa... ELEVIDYS Delivers 3-Year Sustained Motor Benefits in Ambulatory Duchenne Pa... Read Post »
