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 »
New Drug ApprovalHenlius Secures EU Approval for Serplulimab in Lung and Esophageal Cancers Henlius Secures EU Approval for Serplulimab in Lung and Esophageal Cancers Read Post »
New Drug ApprovalFDA Approves Bizengri for Rare NRG1-Positive Cholangiocarcinoma FDA Approves Bizengri for Rare NRG1-Positive Cholangiocarcinoma Read Post »
New Drug ApprovalFDA Approves VYVGART for All Adult gMG Antibody Subtypes FDA Approves VYVGART for All Adult gMG Antibody Subtypes Read Post »
New Drug ApprovalGenentech Wins FDA Approval for Ocrevus in Pediatric Multiple Sclerosis Genentech Wins FDA Approval for Ocrevus in Pediatric Multiple Sclerosis Read Post »
New Drug ApprovalEU Clears BMS’s Sotyktu for Adults With Psoriatic Arthritis EU Clears BMS’s Sotyktu for Adults With Psoriatic Arthritis Read Post »
New Drug ApprovalInnovent Wins NMPA Approval for Multi-Dose Mazdutide Pen in Type 2 Diabetes Innovent Wins NMPA Approval for Multi-Dose Mazdutide Pen in Type 2 Diabetes Read Post »
New Drug ApprovalNICE Recommends Givinostat for Ambulant DMD Patients Aged 6+ via NHS Innova... NICE Recommends Givinostat for Ambulant DMD Patients Aged 6+ via NHS Innova... Read Post »
New Drug ApprovalMHRA Authorizes Dawnzera for Patients With Hereditary Angioedema MHRA Authorizes Dawnzera for Patients With Hereditary Angioedema Read Post »
New Drug ApprovalBridgeBio Gains ANVISA Clearance in Brazil for BEYONTTRA in ATTR-CM BridgeBio Gains ANVISA Clearance in Brazil for BEYONTTRA in ATTR-CM Read Post »
New Drug ApprovalASCENIV Approved for Expanded Pediatric Use in Primary Immunodeficiency ASCENIV Approved for Expanded Pediatric Use in Primary Immunodeficiency Read Post »
New Drug ApprovalFDA Clears VEPPANU, First PROTAC Therapy, for Advanced Breast Cancer FDA Clears VEPPANU, First PROTAC Therapy, for Advanced Breast Cancer Read Post »
New Drug ApprovalMHRA Clears Linerixibat (Lynavoy) for PBC-Related Itch in Adults MHRA Clears Linerixibat (Lynavoy) for PBC-Related Itch in Adults Read Post »
New Drug ApprovalJohnson & Johnson Secures FDA Nod for STELARA in Pediatric Crohn’s Johnson & Johnson Secures FDA Nod for STELARA in Pediatric Crohn’s Read Post »
New Drug ApprovalRhythm Wins EU Approval for IMCIVREE in Acquired Hypothalamic Obesity Rhythm Wins EU Approval for IMCIVREE in Acquired Hypothalamic Obesity Read Post »
New Drug ApprovalArrowhead Breaks the Triglyceride Barrier with REDEMPLO Approval in Austral... Arrowhead Breaks the Triglyceride Barrier with REDEMPLO Approval in Austral... Read Post »
New Drug ApprovalAxsome Wins FDA Decision for Auvelity in Alzheimer’s Agitation Axsome Wins FDA Decision for Auvelity in Alzheimer’s Agitation Read Post »
New Drug ApprovalNorgine Pushes the Frontier of WHIM Treatment With XOLREMDI EU Approval Norgine Pushes the Frontier of WHIM Treatment With XOLREMDI EU Approval Read Post »
New Drug ApprovalMitsubishi Tanabe Brings Steady Control to Parkinson’s with EU Nod for On... Mitsubishi Tanabe Brings Steady Control to Parkinson’s with EU Nod for On... Read Post »
New Drug ApprovalAstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... AstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... Read Post »
New Drug ApprovalNovartis Targets the Root of CSU With EU Approval of Rhapsido Novartis Targets the Root of CSU With EU Approval of Rhapsido Read Post »
New Drug ApprovalJohnson & Johnson Gains FDA Nod for CAPLYTA in Schizophrenia Johnson & Johnson Gains FDA Nod for CAPLYTA in Schizophrenia Read Post »
New Drug ApprovalAstraZeneca Clinches FDA Approval for Saphnelo Autoinjector in SLE AstraZeneca Clinches FDA Approval for Saphnelo Autoinjector in SLE Read Post »
New Drug ApprovalCHMP April 2026 Roundup: Breakthroughs in SMA, MS, and Rare Metabolic Disor... CHMP April 2026 Roundup: Breakthroughs in SMA, MS, and Rare Metabolic Disor... Read Post »
New Drug ApprovalRegeneron Breaks the Silence with Otarmeni, a First-in-Class Hearing Loss G... Regeneron Breaks the Silence with Otarmeni, a First-in-Class Hearing Loss G... Read Post »
New Drug ApprovalDupixent Breaks New Ground in Pediatric Chronic Urticaria Care Dupixent Breaks New Ground in Pediatric Chronic Urticaria Care Read Post »
