New Drug ApprovalSanofi’s Wayrilz Wins Japan Approval for Chronic Immune Thrombocytopenia Sanofi’s Wayrilz Wins Japan Approval for Chronic Immune Thrombocytopenia Read Post »
New Drug ApprovalEU Authorizes MAVIRET for Adults and Children with Acute Hepatitis C EU Authorizes MAVIRET for Adults and Children with Acute Hepatitis C Read Post »
New Drug ApprovalSanofi Wins EU Approval for Cenrifki in Non-Relapsing SPMS Sanofi Wins EU Approval for Cenrifki in Non-Relapsing SPMS Read Post »
New Drug ApprovalJapan Expands Xocova Approval to Children Aged 6–11 Years With COVID-19 Japan Expands Xocova Approval to Children Aged 6–11 Years With COVID-19 Read Post »
New Drug ApprovalJapan Approves Avastin as First-Ever Therapy for Neurofibromatosis Type 2 Japan Approves Avastin as First-Ever Therapy for Neurofibromatosis Type 2 Read Post »
New Drug ApprovalJapan Approves Minjuvi Plus Lenalidomide for Relapsed or Refractory DLBCL Japan Approves Minjuvi Plus Lenalidomide for Relapsed or Refractory DLBCL Read Post »
New Drug ApprovalFDA Expands CAPVAXIVE Approval for Children and Adolescents at Increased Pn... FDA Expands CAPVAXIVE Approval for Children and Adolescents at Increased Pn... Read Post »
New Drug ApprovalUtebzi (Tebipenem Pivoxil) Receives FDA Approval for Adults with cUTI Utebzi (Tebipenem Pivoxil) Receives FDA Approval for Adults with cUTI Read Post »
Lifestyle New Drug Approval WellnessAbbVie Secures FDA Approval for SKINVIVE in Horizontal Neck Wrinkles AbbVie Secures FDA Approval for SKINVIVE in Horizontal Neck Wrinkles Read Post »
New Drug ApprovalFDA Approves Amphastar’s Rextovy OTC Naloxone Spray FDA Approves Amphastar’s Rextovy OTC Naloxone Spray Read Post »
New Drug ApprovalFDA Approves Low-Gadolinium MRI Contrast Agent AMBELVIST FDA Approves Low-Gadolinium MRI Contrast Agent AMBELVIST Read Post »
New Drug ApprovalChina Approves Vanflyta for Newly Diagnosed FLT3-ITD Positive AML China Approves Vanflyta for Newly Diagnosed FLT3-ITD Positive AML Read Post »
New Drug ApprovalFDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... FDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... Read Post »
New Drug ApprovalUK Approves Europe’s First Oral Wegovy for Weight Management UK Approves Europe’s First Oral Wegovy for Weight Management Read Post »
New Drug ApprovalAkeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Akeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Read Post »
New Drug ApprovalFDA Expands Organon’s TOFIDENCE Biosimilar Approval to CAR-T CRS and COVI... FDA Expands Organon’s TOFIDENCE Biosimilar Approval to CAR-T CRS and COVI... Read Post »
New Drug ApprovalFDA Approves Every-8-Week EBGLYSS Dosing for Atopic Dermatitis FDA Approves Every-8-Week EBGLYSS Dosing for Atopic Dermatitis Read Post »
New Drug ApprovalFDA Adds Bemotrizinol to OTC Sunscreen Monograph, First New UV Filter in Ov... FDA Adds Bemotrizinol to OTC Sunscreen Monograph, First New UV Filter in Ov... Read Post »
New Drug ApprovalMHRA Grants Authorization for Nipocalimab in gMG MHRA Grants Authorization for Nipocalimab in gMG Read Post »
New Drug ApprovalEU Approves Sarclisa On-Body Injector Option for Multiple Myeloma EU Approves Sarclisa On-Body Injector Option for Multiple Myeloma Read Post »
New Drug ApprovalFDA Approves HYMPAVZI for Children and Hemophilia Patients With Inhibitors FDA Approves HYMPAVZI for Children and Hemophilia Patients With Inhibitors Read Post »
New Drug ApprovalNMPA Approves Lupeng’s Rocbrutinib, China’s First Fourth-Generation... NMPA Approves Lupeng’s Rocbrutinib, China’s First Fourth-Generation... Read Post »
New Drug ApprovalMHRA Approves First MASH Treatment for Patients With Liver Fibrosis MHRA Approves First MASH Treatment for Patients With Liver Fibrosis Read Post »
New Drug ApprovalAbbVie Secures EU Approval for AQUIPTA in Acute Migraine AbbVie Secures EU Approval for AQUIPTA in Acute Migraine Read Post »
New Drug ApprovalAmgen Wins EU Approval for IMDYLLTRA in Relapsed ES-SCLC Amgen Wins EU Approval for IMDYLLTRA in Relapsed ES-SCLC Read Post »
New Drug ApprovalShionogi Wins FDA Approval for First Oral XOCOVA to Prevent COVID-19 After ... Shionogi Wins FDA Approval for First Oral XOCOVA to Prevent COVID-19 After ... Read Post »
New Drug ApprovalFDA Approves First Inhaled Mealtime Insulin for Pediatric Diabetes FDA Approves First Inhaled Mealtime Insulin for Pediatric Diabetes Read Post »
New Drug ApprovalFDA Approves Wockhardt’s ZAYNICH; India Also Grants Authorization FDA Approves Wockhardt’s ZAYNICH; India Also Grants Authorization Read Post »
New Drug ApprovalEuropean Commission Authorizes New VENCLYXTO Regimens for CLL European Commission Authorizes New VENCLYXTO Regimens for CLL Read Post »
New Drug ApprovalImfinzi Cuts Recurrence Risk by 32% and Wins FDA Approval in High-Risk NMIB... Imfinzi Cuts Recurrence Risk by 32% and Wins FDA Approval in High-Risk NMIB... Read Post »
New Drug ApprovalIronwood and AbbVie Secure FDA Expansion for LINZESS in Young Children for ... Ironwood and AbbVie Secure FDA Expansion for LINZESS in Young Children for ... Read Post »
New Drug ApprovalFDA Clears AbbVie’s DECNUPAZ as First CD123 ADC for BPDCN FDA Clears AbbVie’s DECNUPAZ as First CD123 ADC for BPDCN Read Post »
New Drug ApprovalApotex Wins Health Canada Approval for IHEEZO Eye Anesthetic Gel Apotex Wins Health Canada Approval for IHEEZO Eye Anesthetic Gel Read Post »
New Drug ApprovalVyepti Wins South Korea Approval for Adult Migraine Vyepti Wins South Korea Approval for Adult Migraine Read Post »
New Drug ApprovalEC Approves Pharming’s Joenja for Activated PI3K Delta Syndrome EC Approves Pharming’s Joenja for Activated PI3K Delta Syndrome Read Post »
New Drug ApprovalGalderma Wins FDA Approval for OTC Differin Epiduo Acne Gel Galderma Wins FDA Approval for OTC Differin Epiduo Acne Gel Read Post »
New Drug ApprovalEC Grants EU‑Wide Approval for PYRUKYND in Thalassemia EC Grants EU‑Wide Approval for PYRUKYND in Thalassemia Read Post »
New Drug ApprovalAstraZeneca and Daiichi Sankyo Secure FDA Approval for Datroway in Frontlin... AstraZeneca and Daiichi Sankyo Secure FDA Approval for Datroway in Frontlin... Read Post »
New Drug ApprovalGilead’s Hepcludex Becomes First FDA-Approved HDV Therapy Gilead’s Hepcludex Becomes First FDA-Approved HDV Therapy Read Post »
New Drug ApprovalBayer Wins NMPA Approval for Kerendia in HFmrEF/HFpEF Bayer Wins NMPA Approval for Kerendia in HFmrEF/HFpEF Read Post »
New Drug ApprovalHERNEXEOS Secures China Approval for Untreated HER2-Mutant NSCLC HERNEXEOS Secures China Approval for Untreated HER2-Mutant NSCLC Read Post »
New Drug ApprovalJapan Expands GSK’s Arexvy Approval to At-Risk Adults Aged 18–49 Japan Expands GSK’s Arexvy Approval to At-Risk Adults Aged 18–49 Read Post »
New Drug ApprovalBoehringer Ingelheim Secures Japan Approval for JASCAYD in Pulmonary Fibros... Boehringer Ingelheim Secures Japan Approval for JASCAYD in Pulmonary Fibros... Read Post »
New Drug ApprovalFDA Approves AstraZeneca’s Baxfendy, an Aldosterone-Targeting Therapy... FDA Approves AstraZeneca’s Baxfendy, an Aldosterone-Targeting Therapy... Read Post »
New Drug ApprovalFDA Approves Tecentriq as First ctDNA-Guided Therapy for Bladder Cancer FDA Approves Tecentriq as First ctDNA-Guided Therapy for Bladder Cancer Read Post »
New Drug ApprovalMHRA Approves Vyjuvek for Dystrophic Epidermolysis Bullosa MHRA Approves Vyjuvek for Dystrophic Epidermolysis Bullosa Read Post »
New Drug ApprovalFDA Approves Enhertu After Positive DESTINY-Breast Phase III Results FDA Approves Enhertu After Positive DESTINY-Breast Phase III Results Read Post »
New Drug ApprovalTaiho’s INQOVI With Venetoclax Approved for Patients Unable to Receive In... Taiho’s INQOVI With Venetoclax Approved for Patients Unable to Receive In... Read Post »
New Drug ApprovalBeOne Gains FDA Accelerated Approval for BEQALZI in MCL BeOne Gains FDA Accelerated Approval for BEQALZI in MCL Read Post »
New Drug ApprovalEuropean Commission Approves Pfizer’s HYMPAVZI for Haemophilia Patients European Commission Approves Pfizer’s HYMPAVZI for Haemophilia Patients Read Post »
