New Drug ApprovalHealth Canada Approves REDEMPLO (plozasiran) for Familial Chylomicronemia S... Health Canada Approves REDEMPLO (plozasiran) for Familial Chylomicronemia S... Read Post »
Health Tidings ResearchAbbott Launches Libre Assist in Libre App to Improve In-the-Moment Food Dec... Abbott Launches Libre Assist in Libre App to Improve In-the-Moment Food Dec... Read Post »
New Drug ApprovalModerna Files With FDA, EMA, Health Canada and TGA for New mRNA Flu Shot Moderna Files With FDA, EMA, Health Canada and TGA for New mRNA Flu Shot Read Post »
New Drug ApprovalAltimmune’s Pemvidutide Granted FDA Breakthrough Therapy Designation for ... Altimmune’s Pemvidutide Granted FDA Breakthrough Therapy Designation for ... Read Post »
New Drug ApprovalGSK’s Nucala (Mepolizumab) Gains China NMPA Approval for Eosinophilic... GSK’s Nucala (Mepolizumab) Gains China NMPA Approval for Eosinophilic... Read Post »
New Drug ApprovalSanofi’s Tzield (Teplizumab) Gains FDA Priority Review for 1-Year-Old... Sanofi’s Tzield (Teplizumab) Gains FDA Priority Review for 1-Year-Old... Read Post »
New Drug ApprovalMHRA Approves Kostaive (Zapomeran) sa-mRNA COVID Booster for UK Adults-Key ... MHRA Approves Kostaive (Zapomeran) sa-mRNA COVID Booster for UK Adults-Key ... Read Post »
New Drug ApprovalUltragenyx Completes Rolling BLA for First-in-Class DTX401 Gene Therapy in ... Ultragenyx Completes Rolling BLA for First-in-Class DTX401 Gene Therapy in ... Read Post »
ResearchPolyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocke... Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocke... Read Post »
Drugs Safety Alert ResearchNimesulide’s Rise and Reckoning in India: Ending with a Nationwide Ban on... Nimesulide’s Rise and Reckoning in India: Ending with a Nationwide Ban on... Read Post »
Drugs Safety AlertFDA Adds New Safety Warning to ALTUVIIIO Label FDA Adds New Safety Warning to ALTUVIIIO Label Read Post »
New Drug ApprovalFDA Accepts Axsome’s AXS-05 Supplemental NDA and Grants Priority Review f... FDA Accepts Axsome’s AXS-05 Supplemental NDA and Grants Priority Review f... Read Post »
Health Tidings ResearchFDA Issues Third CRL for Outlook Therapeutics’ ONS-5010/LYTENAVA in W... FDA Issues Third CRL for Outlook Therapeutics’ ONS-5010/LYTENAVA in W... Read Post »
Drugs Safety Alert ResearchSemaglutide and Eye Health: A Look at NAION Risk Semaglutide and Eye Health: A Look at NAION Risk Read Post »
Health Tidings ResearchCorcept Therapeutics Receives FDA Complete Response Letter for Relacorilant... Corcept Therapeutics Receives FDA Complete Response Letter for Relacorilant... Read Post »
New Drug ApprovalFDA Clears NEREUS, First New Motion Sickness Drug in Decades FDA Clears NEREUS, First New Motion Sickness Drug in Decades Read Post »
Clinical TrailsDenali’s Tividenofusp Alfa (DNL310) Phase 1/2 Data in Hunter Syndrome wit... Denali’s Tividenofusp Alfa (DNL310) Phase 1/2 Data in Hunter Syndrome wit... Read Post »
New Drug ApprovalUnicycive Resubmits NDA for Oxylanthanum Carbonate for Hyperphosphatemia Ma... Unicycive Resubmits NDA for Oxylanthanum Carbonate for Hyperphosphatemia Ma... Read Post »
New Drug ApprovalFDA Grants Breakthrough Therapy to Ulixacaltamide (PRAX-944) for Essential ... FDA Grants Breakthrough Therapy to Ulixacaltamide (PRAX-944) for Essential ... Read Post »
Health Tidings ResearchGenmab Halts Clinical Development of Acasunlimab After Portfolio Review, Sh... Genmab Halts Clinical Development of Acasunlimab After Portfolio Review, Sh... Read Post »
Drugs Safety Alert ResearchFDA Says PFAS Safety in Cosmetics Remains Uncertain Due to Data Gaps FDA Says PFAS Safety in Cosmetics Remains Uncertain Due to Data Gaps Read Post »
New Drug ApprovalFirst-in-Class TRPV1 Inhibitor Avarept Approved in Japan for Dry Eye Diseas... First-in-Class TRPV1 Inhibitor Avarept Approved in Japan for Dry Eye Diseas... Read Post »
New Drug Approval ResearchGrifols’ FESILTY (Fibrinogen): Evidence, Safety, and Clinical Use Explain... Grifols’ FESILTY (Fibrinogen): Evidence, Safety, and Clinical Use Explain... Read Post »
Clinical TrailsGalapagos GLPG3667 Meets Primary Endpoint in Dermatomyositis Phase 3-Enabli... Galapagos GLPG3667 Meets Primary Endpoint in Dermatomyositis Phase 3-Enabli... Read Post »
Clinical TrailsTirzepatide Matches Dulaglutide on Major Cardiovascular Outcomes in SURPASS... Tirzepatide Matches Dulaglutide on Major Cardiovascular Outcomes in SURPASS... Read Post »
Clinical TrailsJohnson and Johnson’s JNJ-5939 Falls Short in DUPLEX-AD Phase 2b Trial fo... Johnson and Johnson’s JNJ-5939 Falls Short in DUPLEX-AD Phase 2b Trial fo... Read Post »
New Drug ApprovalENHERTU Approved in China for HER2-Low and HER2-Ultralow Metastatic Breast ... ENHERTU Approved in China for HER2-Low and HER2-Ultralow Metastatic Breast ... Read Post »
New Drug ApprovalFDA Approves YARTEMLEA: First TA-TMA Therapy Post-Stem Cell Transplant FDA Approves YARTEMLEA: First TA-TMA Therapy Post-Stem Cell Transplant Read Post »
Clinical TrailsBiogen Reports Final VALOR Results Showing Earlier QALSODY Treatment May Sl... Biogen Reports Final VALOR Results Showing Earlier QALSODY Treatment May Sl... Read Post »
New Drug ApprovalIncyte’s Zynyz Receives First Approval in Japan for Advanced SCAC Incyte’s Zynyz Receives First Approval in Japan for Advanced SCAC Read Post »
New Drug ApprovalJapan Expands Pediatric Asthma Treatment with Dupixent Approval Japan Expands Pediatric Asthma Treatment with Dupixent Approval Read Post »
Clinical TrailsNeurocrine’s Phase 3 KINECT-DCP Trial of Valbenazine Fails to Meet En... Neurocrine’s Phase 3 KINECT-DCP Trial of Valbenazine Fails to Meet En... Read Post »
New Drug ApprovalZai Lab Wins China Approval for COBENFY, a First-in-Class Muscarinic Therap... Zai Lab Wins China Approval for COBENFY, a First-in-Class Muscarinic Therap... Read Post »
New Drug ApprovalU.S. FDA Approves Agios’ AQVESME (Mitapivat) as First Treatment for Anemi... U.S. FDA Approves Agios’ AQVESME (Mitapivat) as First Treatment for Anemi... Read Post »
Drugs Safety Alert ResearchPreliminary Safety Update: Pfizer Notifies Hemophilia Community of Death in... Preliminary Safety Update: Pfizer Notifies Hemophilia Community of Death in... Read Post »
New Drug ApprovalJapan Approves Finerenone for Chronic Heart Failure with Preserved or Mildl... Japan Approves Finerenone for Chronic Heart Failure with Preserved or Mildl... Read Post »
New Drug ApprovalEuropean Commission Approves TREMFYA® (guselkumab) for Paediatric Plaque P... European Commission Approves TREMFYA® (guselkumab) for Paediatric Plaque P... Read Post »
New Drug ApprovalNovo Nordisk’s Wegovy Pill Wins FDA Approval Following OASIS Trial Result... Novo Nordisk’s Wegovy Pill Wins FDA Approval Following OASIS Trial Result... Read Post »
New Drug ApprovalSubcutaneous Lunsumio VELO™ Approved: 75% ORR in Heavily Pretreated Folli... Subcutaneous Lunsumio VELO™ Approved: 75% ORR in Heavily Pretreated Folli... Read Post »
Drugs Safety Alert ResearchJAMA Study Analysing 20 Years of U.S. Data Links GLP-1 Drugs With Persisten... JAMA Study Analysing 20 Years of U.S. Data Links GLP-1 Drugs With Persisten... Read Post »
Clinical TrailsInsmed’s Brensocatib Misses Endpoints in Phase 2b BiRCh Trial for Chronic... Insmed’s Brensocatib Misses Endpoints in Phase 2b BiRCh Trial for Chronic... Read Post »
Drugs Safety Alert ResearchFDA Safety Update: Andexxa Risks Outweigh Benefits After Postmarketing Thro... FDA Safety Update: Andexxa Risks Outweigh Benefits After Postmarketing Thro... Read Post »
Clinical TrailsPhase II FALKON Trial Discontinued After Fidrisertib Fails in FOP Phase II FALKON Trial Discontinued After Fidrisertib Fails in FOP Read Post »
New Drug ApprovalMYQORZO Aficamten FDA Approval: Breakthrough for Symptomatic oHCM Treatment... MYQORZO Aficamten FDA Approval: Breakthrough for Symptomatic oHCM Treatment... Read Post »
Clinical TrailsLilly’s Orforglipron Maintains Weight Loss Post-Wegovy/Zepbound in AT... Lilly’s Orforglipron Maintains Weight Loss Post-Wegovy/Zepbound in AT... Read Post »
Clinical TrailsTakeda’s Zasocitinib Hits All Phase 3 Endpoints in Plaque Psoriasis: ... Takeda’s Zasocitinib Hits All Phase 3 Endpoints in Plaque Psoriasis: ... Read Post »
New Drug ApprovalFDA Approves Expanded Indication for Johnson & Johnson’s TRUFILL n‑... FDA Approves Expanded Indication for Johnson & Johnson’s TRUFILL n‑... Read Post »
New Drug ApprovalNovo Nordisk Pushes Obesity Innovation Forward With FDA Filing for CagriSem... Novo Nordisk Pushes Obesity Innovation Forward With FDA Filing for CagriSem... Read Post »
New Drug ApprovalinMIND Trial Success: Minjuvi (Tafasitamab) Now EU-Approved for Relapsed Fo... inMIND Trial Success: Minjuvi (Tafasitamab) Now EU-Approved for Relapsed Fo... Read Post »
Health Tidings ResearchFDA Grants Advanced Manufacturing Technology Designation to Astellas’ Mah... FDA Grants Advanced Manufacturing Technology Designation to Astellas’ Mah... Read Post »
