Health TidingsWegovy Pill Now Available in the U.S.: First Oral GLP-1 Weight-Loss Medicin... Wegovy Pill Now Available in the U.S.: First Oral GLP-1 Weight-Loss Medicin... 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 »
Health TidingsNovo Nordisk Wins Final Patent Ruling on Semaglutide in China Novo Nordisk Wins Final Patent Ruling on Semaglutide in China 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 »
Policy & AcquisitionsJohnson & Johnson Finalizes Acquisition of Halda Therapeutics Johnson & Johnson Finalizes Acquisition of Halda Therapeutics 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 »
Food WellnessDoes Yogurt Prevent Antibiotic-Associated Diarrhea? What the Research Shows Does Yogurt Prevent Antibiotic-Associated Diarrhea? What the Research Shows 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 »
Health TidingsEnvafolimab Granted FDA Orphan Drug Designation for Gastric and GEJ Cancer:... Envafolimab Granted FDA Orphan Drug Designation for Gastric and GEJ Cancer:... 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 »
Policy & AcquisitionsSanofi to Acquire Dynavax, Strengthening Adult Vaccine Portfolio with HEPLI... Sanofi to Acquire Dynavax, Strengthening Adult Vaccine Portfolio with HEPLI... Read Post »
Health TidingsFDA Issues CRL for Sanofi’s Tolebrutinib in Non-Relapsing Secondary Progr... FDA Issues CRL for Sanofi’s Tolebrutinib in Non-Relapsing Secondary Progr... 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 »
Wellness Women & Child HealthHydration and UTIs: How Drinking Water Supports Antibiotic Treatment Hydration and UTIs: How Drinking Water Supports Antibiotic Treatment 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 »
Health TidingsIpsen licenses SIM0613 ADC from Simcere Zaiming, targeting Phase I in 2026 Ipsen licenses SIM0613 ADC from Simcere Zaiming, targeting Phase I in 2026 Read Post »
Health TidingsJ&J Supports HRS Registry to Advance PFA Evidence in AFib J&J Supports HRS Registry to Advance PFA Evidence in AFib 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 »
Lifestyle WellnessAlcohol and Sleeping Pills: Why This Combination Makes Drowsiness Dangerous Alcohol and Sleeping Pills: Why This Combination Makes Drowsiness Dangerous 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 »
