New Drug ApprovalFDA Accelerates Approval of Otsuka’s VOYXACT® (sibeprenlimab-szsi) for I... FDA Accelerates Approval of Otsuka’s VOYXACT® (sibeprenlimab-szsi) for I... Read Post »
Clinical Trials New Drug ApprovalNovo Nordisk Files FDA sNDA for Wegovy 7.2 mg Higher Dose After 20.7% Weigh... Novo Nordisk Files FDA sNDA for Wegovy 7.2 mg Higher Dose After 20.7% Weigh... Read Post »
New Drug ApprovalFDA Approves Imfinzi as First and Only Perioperative Immunotherapy for Earl... FDA Approves Imfinzi as First and Only Perioperative Immunotherapy for Earl... Read Post »
New Drug ApprovalSanofi and Regeneron’s Dupixent Wins EU Approval as First Targeted Therap... Sanofi and Regeneron’s Dupixent Wins EU Approval as First Targeted Therap... Read Post »
New Drug ApprovalSerum Institute of India’s SIILTIBCY® Receives MHRA Authorization in... Serum Institute of India’s SIILTIBCY® Receives MHRA Authorization in... Read Post »
New Drug ApprovalFDA Approves Itvisma (Onasemnogene Abeparvovec-brve), the First Intrathecal... FDA Approves Itvisma (Onasemnogene Abeparvovec-brve), the First Intrathecal... Read Post »
New Drug ApprovalKoselugo Approved by FDA for Adults with Neurofibromatosis Type 1: A New Tr... Koselugo Approved by FDA for Adults with Neurofibromatosis Type 1: A New Tr... Read Post »
New Drug ApprovalFDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ with Padcev® ... FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ with Padcev® ... Read Post »
New Drug ApprovalFDA Grants Full Approval to AbbVie’s EPKINLY® (epcoritamab-bysp) Plu... FDA Grants Full Approval to AbbVie’s EPKINLY® (epcoritamab-bysp) Plu... Read Post »
New Drug ApprovalFDA Clears Regeneron and Bayer’s EYLEA HD® for Macular Edema after R... FDA Clears Regeneron and Bayer’s EYLEA HD® for Macular Edema after R... Read Post »
New Drug ApprovalFDA Approves Redemplo (Plozasiran) to Lower Triglycerides in Adults with Fa... FDA Approves Redemplo (Plozasiran) to Lower Triglycerides in Adults with Fa... Read Post »
New Drug ApprovalEMA CHMP November 2025: Ten New Medicines Recommended for Approval EMA CHMP November 2025: Ten New Medicines Recommended for Approval Read Post »
New Drug ApprovalSandoz Launches Tyruko® in US, First Biosimilar to Biogen’s Tysabri, Enh... Sandoz Launches Tyruko® in US, First Biosimilar to Biogen’s Tysabri, Enh... Read Post »
New Drug ApprovalFDA Approves Linzess (Linaclotide) for Pediatric IBS-C: A Game Changer in T... FDA Approves Linzess (Linaclotide) for Pediatric IBS-C: A Game Changer in T... Read Post »
New Drug ApprovalInnovative Brekiya® DHE Autoinjector Launched by Amneal for Rapid Relief o... Innovative Brekiya® DHE Autoinjector Launched by Amneal for Rapid Relief o... Read Post »
New Drug ApprovalKygevvi Brings Hope for Patients With Rare Mitochondrial Disorder Kygevvi Brings Hope for Patients With Rare Mitochondrial Disorder Read Post »
Disease & Drugs New Drug ApprovalNew FDA Indication for WINREVAIR: Reducing Hospitalizations and Mortality i... New FDA Indication for WINREVAIR: Reducing Hospitalizations and Mortality i... Read Post »
New Drug ApprovalBayer’s Lynkuet: FDA Approves Non-Hormonal Pill for Hot Flashes in Menopa... Bayer’s Lynkuet: FDA Approves Non-Hormonal Pill for Hot Flashes in Menopa... Read Post »
New Drug ApprovalLupin Launches Authorized Generic and Endo Launches First Generic Versions ... Lupin Launches Authorized Generic and Endo Launches First Generic Versions ... Read Post »
New Drug ApprovalFDA Re-approves GSK’s Blenrep (Belantamab Mafodotin-blmf) Combo for Relap... FDA Re-approves GSK’s Blenrep (Belantamab Mafodotin-blmf) Combo for Relap... Read Post »
New Drug ApprovalFDA Expands Approval of Revumenib for NPM1-Mutated Relapsed or Refractory A... FDA Expands Approval of Revumenib for NPM1-Mutated Relapsed or Refractory A... Read Post »
Health Tidings New Drug ApprovalMounjaro Now Cipla’s Yurpeak: A New Chapter for Tirzepatide in India Mounjaro Now Cipla’s Yurpeak: A New Chapter for Tirzepatide in India Read Post »
New Drug ApprovalGlaukos’ Epioxa™ Wins FDA Nod: A Game-Changer for Keratoconus Patients Glaukos’ Epioxa™ Wins FDA Nod: A Game-Changer for Keratoconus Patients Read Post »
New Drug ApprovalFDA Approves Gazyva for Lupus Nephritis, Extending Roche and Biogen’s CD2... FDA Approves Gazyva for Lupus Nephritis, Extending Roche and Biogen’s CD2... Read Post »
New Drug ApprovalFDA Approves Lasix ONYU: At-Home Drug-Device Combination for Subcutaneous F... FDA Approves Lasix ONYU: At-Home Drug-Device Combination for Subcutaneous F... Read Post »
New Drug ApprovalFDA Approves Libtayo® (cemiplimab-rwlc) for Adjuvant Treatment of High-Ris... FDA Approves Libtayo® (cemiplimab-rwlc) for Adjuvant Treatment of High-Ris... Read Post »
New Drug ApprovalFDA Clears Simponi (Golimumab) for Children with Ulcerative Colitis FDA Clears Simponi (Golimumab) for Children with Ulcerative Colitis Read Post »
New Drug ApprovalJascayd (Nerandomilast) Receives FDA Nod for Idiopathic Pulmonary Fibrosis Jascayd (Nerandomilast) Receives FDA Nod for Idiopathic Pulmonary Fibrosis Read Post »
Clinical Trials New Drug ApprovalFDA Approves Arcutis’ Zoryve (Roflumilast) Cream 0.05% for Mild to Modera... FDA Approves Arcutis’ Zoryve (Roflumilast) Cream 0.05% for Mild to Modera... Read Post »
Clinical Trials New Drug ApprovalIntroducing Ozempic in India: A Breakthrough in Type 2 Diabetes and Weight ... Introducing Ozempic in India: A Breakthrough in Type 2 Diabetes and Weight ... Read Post »
Clinical Trials New Drug ApprovalFDA Approves Jazz’s Zepzelca plus Roche’s Tecentriq for Extensive-S... FDA Approves Jazz’s Zepzelca plus Roche’s Tecentriq for Extensive-S... Read Post »
Clinical Trials New Drug ApprovalFDA Approval of Rhapsido® (remibrutinib) for Chronic Spontaneous Urticaria... FDA Approval of Rhapsido® (remibrutinib) for Chronic Spontaneous Urticaria... Read Post »
New Drug ApprovalFDA Expands Tremfya Approval to Children with Plaque Psoriasis and Psoriati... FDA Expands Tremfya Approval to Children with Plaque Psoriasis and Psoriati... Read Post »
Clinical Trials New Drug ApprovalFDA approves Palsonify (paltusotine) a once-daily oral option for adults wi... FDA approves Palsonify (paltusotine) a once-daily oral option for adults wi... Read Post »
Clinical Trials New Drug ApprovalFDA Authorizes Essilor Stellest™ Lenses to Slow Childhood Myopia FDA Authorizes Essilor Stellest™ Lenses to Slow Childhood Myopia Read Post »
Clinical Trials New Drug ApprovalFDA Approves Inluriyo for ESR1-Mutated Advanced Breast Cancer FDA Approves Inluriyo for ESR1-Mutated Advanced Breast Cancer Read Post »
New Drug ApprovalForzinity (Elamipretide) wins accelerated approval-the first FDA-approved t... Forzinity (Elamipretide) wins accelerated approval-the first FDA-approved t... Read Post »
New Drug ApprovalProtecting the Tiny Lungs: Clesrovimab Brings New Hope against Respiratory ... Protecting the Tiny Lungs: Clesrovimab Brings New Hope against Respiratory ... Read Post »
New Drug ApprovalFDA Approves Enbumyst (bumetanide) Nasal Spray to Treat Edema from Heart, L... FDA Approves Enbumyst (bumetanide) Nasal Spray to Treat Edema from Heart, L... Read Post »
New Drug ApprovalFDA Approves J&J’s Inlexzo for BCG-Unresponsive Bladder Cancer FDA Approves J&J’s Inlexzo for BCG-Unresponsive Bladder Cancer Read Post »
New Drug ApprovalFDA Approves Sanofi’s WAYRILZ (rilzabrutinib) Tablets for Adult Patients ... FDA Approves Sanofi’s WAYRILZ (rilzabrutinib) Tablets for Adult Patients ... Read Post »
New Drug ApprovalPatients Gain a New Way to Continue Alzheimer’s Treatment as FDA Authoriz... Patients Gain a New Way to Continue Alzheimer’s Treatment as FDA Authoriz... Read Post »
New Drug Approval“FDA Gives Nod to Lynozyfic, Bringing New Hope for Relapsed or Refractory... “FDA Gives Nod to Lynozyfic, Bringing New Hope for Relapsed or Refractory... Read Post »
New Drug Approval“FDA Approval of VIZZ Brings Hope for Presbyopia Patients” “FDA Approval of VIZZ Brings Hope for Presbyopia Patients” Read Post »
New Drug ApprovalSun Pharma Launches LEQSELVI™ in the U.S. for Severe Alopecia Areata afte... Sun Pharma Launches LEQSELVI™ in the U.S. for Severe Alopecia Areata afte... Read Post »
New Drug ApprovalNovartis’s First-ever Malaria Treatment for Newborns under 5 kg- Coarte... Novartis’s First-ever Malaria Treatment for Newborns under 5 kg- Coarte... Read Post »
New Drug Approval“Gilead’s Yeztugo (Lenacapavir) Receives FDA Nod as First Twice-Yearly ... “Gilead’s Yeztugo (Lenacapavir) Receives FDA Nod as First Twice-Yearly ... Read Post »
New Drug ApprovalModerna Launches mNEXSPIKE: New FDA-Approved COVID Vaccine for High-Risk Gr... Moderna Launches mNEXSPIKE: New FDA-Approved COVID Vaccine for High-Risk Gr... Read Post »
New Drug ApprovalYutrepia (Treprostinil) Inhalation Powder developed on Liquidia’s PRI... Yutrepia (Treprostinil) Inhalation Powder developed on Liquidia’s PRI... Read Post »
New Drug Approval“Teal Wand Becomes First FDA Approved At Home Cervical Cancer Screeni... “Teal Wand Becomes First FDA Approved At Home Cervical Cancer Screeni... Read Post »
