New Drug ApprovalAbbVie’s VENCLEXTA Taps AZ’s Acalabrutinib for FDA’s Firs... AbbVie’s VENCLEXTA Taps AZ’s Acalabrutinib for FDA’s Firs... Read Post »
New Drug ApprovalEuropean Commission Grants Conditional Approval for ANKTIVA® in BCG-Unresp... European Commission Grants Conditional Approval for ANKTIVA® in BCG-Unresp... Read Post »
Clinical TrialsViiV Healthcare’s Cabenuva Demonstrates Superior Efficacy in LATITUDE... ViiV Healthcare’s Cabenuva Demonstrates Superior Efficacy in LATITUDE... Read Post »
Clinical TrialsMerck’s ENFLONSIA Shows Promising Safety in Second RSV Season for Hig... Merck’s ENFLONSIA Shows Promising Safety in Second RSV Season for Hig... Read Post »
Clinical TrialsPfizer Advances BRAFTOVI in Colorectal Cancer with New BREAKWATER Results Pfizer Advances BRAFTOVI in Colorectal Cancer with New BREAKWATER Results Read Post »
Clinical TrialsNovartis’ Remibrutinib Shows Promise in Chronic Inducible Urticaria Novartis’ Remibrutinib Shows Promise in Chronic Inducible Urticaria Read Post »
New Drug ApprovalFDA Approves Simplified Monthly Dosing for RYBREVANT FASPRO™ in EGFR-Muta... FDA Approves Simplified Monthly Dosing for RYBREVANT FASPRO™ in EGFR-Muta... Read Post »
Clinical TrialsViiV Healthcare Highlights Lotivibart and Cabotegravir LA Findings at CROI ... ViiV Healthcare Highlights Lotivibart and Cabotegravir LA Findings at CROI ... Read Post »
Clinical TrialsOcular Therapeutix’s AXPAXLI Achieves Superiority in Wet AMD Phase 3 ... Ocular Therapeutix’s AXPAXLI Achieves Superiority in Wet AMD Phase 3 ... Read Post »
New Drug ApprovalGSK’s Exdensur Gains EU Approval for Severe Asthma and CRSwNP GSK’s Exdensur Gains EU Approval for Severe Asthma and CRSwNP Read Post »
Clinical TrialsSanofi and Teva Report Durable Duvakitug Efficacy at 44 Weeks in UC/CD: REL... Sanofi and Teva Report Durable Duvakitug Efficacy at 44 Weeks in UC/CD: REL... Read Post »
Clinical TrialsUltragenyx Reports Long-Term Success of UX111 Gene Therapy for Sanfilippo S... Ultragenyx Reports Long-Term Success of UX111 Gene Therapy for Sanfilippo S... Read Post »
Drugs Safety AlertValneva’s IXCHIQ Gets UK Safety Restrictions for Older Adults Valneva’s IXCHIQ Gets UK Safety Restrictions for Older Adults Read Post »
Clinical TrialsRoche’s Gazyva/Gazyvaro Hits pMN Remission in Phase III MAJESTY Trial Roche’s Gazyva/Gazyvaro Hits pMN Remission in Phase III MAJESTY Trial Read Post »
Clinical TrialsSanofi’s NIRSE-GAL Study Shows Beyfortus Protect Infants Beyond First RSV... Sanofi’s NIRSE-GAL Study Shows Beyfortus Protect Infants Beyond First RSV... Read Post »
Drugs Safety AlertFDA Approves Genzyme’s Thymoglobulin® and Gamida Cell’s Omisirge L... FDA Approves Genzyme’s Thymoglobulin® and Gamida Cell’s Omisirge L... Read Post »
Drugs Safety AlertLevamisole to be Withdrawn from EU Market Over Leukoencephalopathy Risk Levamisole to be Withdrawn from EU Market Over Leukoencephalopathy Risk Read Post »
Drugs Safety AlertWhat’s New in the FDA’s iPLEDGE REMS Update for Isotretinoin What’s New in the FDA’s iPLEDGE REMS Update for Isotretinoin Read Post »
Clinical TrialsNovartis Vanrafia® Slows IgAN Kidney Decline Novartis Vanrafia® Slows IgAN Kidney Decline Read Post »
New Drug ApprovalAmgen’s UPLIZNA® Approved for gMG in EU Amgen’s UPLIZNA® Approved for gMG in EU Read Post »
Clinical TrialsAstraZeneca Breztri Boosts FEV1 in Asthma Trials AstraZeneca Breztri Boosts FEV1 in Asthma Trials Read Post »
Clinical TrialsLundbeck Reports Positive Phase IIb Results for Bocunebart in Migraine Lundbeck Reports Positive Phase IIb Results for Bocunebart in Migraine Read Post »
Clinical TrialsINmune Bio Advances XPro1595 to FDA-Aligned AD Trial INmune Bio Advances XPro1595 to FDA-Aligned AD Trial Read Post »
Drugs Safety AlertFDA Removes Boxed Warning from Menopausal Hormone Therapy Labels FDA Removes Boxed Warning from Menopausal Hormone Therapy Labels Read Post »
Clinical TrialsBridgeBio’s Infigratinib Achieves Breakthrough Phase 3 Results in Ach... BridgeBio’s Infigratinib Achieves Breakthrough Phase 3 Results in Ach... Read Post »
Clinical TrialsINSIGHTT Trial Approved: Sarepta’s HD Therapy Advances INSIGHTT Trial Approved: Sarepta’s HD Therapy Advances Read Post »
New Drug ApprovalKEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ Approved in Combination The... KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ Approved in Combination The... Read Post »
New Drug ApprovalNovocure’s Optune Pax Receives FDA Approval in Pancreatic Cancer Novocure’s Optune Pax Receives FDA Approval in Pancreatic Cancer Read Post »
Clinical TrialsFDA Clears ArkBio’s AK3280 IND for Phase 2 IPF Trial FDA Clears ArkBio’s AK3280 IND for Phase 2 IPF Trial Read Post »
Drugs Safety AlertNIH Stops Low-Dose Rivaroxaban Arm in CAPTIVA Trial Over Safety Concerns NIH Stops Low-Dose Rivaroxaban Arm in CAPTIVA Trial Over Safety Concerns Read Post »
Clinical Trials Drugs Safety AlertChugai’s NXT007 Shows Promising Safety During Emicizumab Transition in Ha... Chugai’s NXT007 Shows Promising Safety During Emicizumab Transition in Ha... Read Post »
Clinical TrialsGSK’s Arexvy RSV Vaccine Accepted for Review in China GSK’s Arexvy RSV Vaccine Accepted for Review in China Read Post »
Clinical TrialsAstraZeneca Advances Oral GLP-1 Elecoglipron Toward Phase III AstraZeneca Advances Oral GLP-1 Elecoglipron Toward Phase III Read Post »
Clinical TrialsKyowa Kirin Takes Full Global Control of Rocatinlimab After Amgen Exit Kyowa Kirin Takes Full Global Control of Rocatinlimab After Amgen Exit Read Post »
Policy & Acquisitions ResearchMexico Partners with Moderna to Boost mRNA Manufacturing and Preparedness Mexico Partners with Moderna to Boost mRNA Manufacturing and Preparedness Read Post »
Clinical TrialsTakeda Announces FDA Acceptance of Oveporexton NDA for NT1 Takeda Announces FDA Acceptance of Oveporexton NDA for NT1 Read Post »
Clinical TrialsRoche’s Fenebrutinib Meets Phase III Endpoint in PPMS Roche’s Fenebrutinib Meets Phase III Endpoint in PPMS Read Post »
Clinical TrialsJohnson & Johnson Reports Results from OMNY-AF Study in A-Fib Johnson & Johnson Reports Results from OMNY-AF Study in A-Fib Read Post »
New Drug ApprovalGSK’s Nucala Secures European Approval for Eosinophilic COPD GSK’s Nucala Secures European Approval for Eosinophilic COPD Read Post »
Clinical TrialsFDA Lifts Prior PCNSL Use Limitation from Gilead’s Yescarta Label FDA Lifts Prior PCNSL Use Limitation from Gilead’s Yescarta Label Read Post »
Clinical TrialsDenali Therapeutics Highlights ETV Platform Progress at WORLDSymposium 2026 Denali Therapeutics Highlights ETV Platform Progress at WORLDSymposium 2026 Read Post »
Clinical TrialsPfizer’s HYMPAVZI Secures FDA Priority Review for Kids Pfizer’s HYMPAVZI Secures FDA Priority Review for Kids Read Post »
Drugs Safety AlertFDA Revises Capecitabine and 5-FU Labels to Address DPD Deficiency Risk FDA Revises Capecitabine and 5-FU Labels to Address DPD Deficiency Risk Read Post »
Clinical TrialsFDA Grants Orphan Drug Designation to Zenocutuzumab for NRG1-Fusion Cholang... FDA Grants Orphan Drug Designation to Zenocutuzumab for NRG1-Fusion Cholang... Read Post »
Clinical TrialsBayer’s Asundexian Cuts Stroke Risk 26% in Phase III Bayer’s Asundexian Cuts Stroke Risk 26% in Phase III Read Post »
New Drug ApprovalFDA Approves VYBRIQUE as First Oral Film for Erectile Dysfunction FDA Approves VYBRIQUE as First Oral Film for Erectile Dysfunction Read Post »
New Drug ApprovalAbbVie Seeks FDA, EMA Approval of RINVOQ in Vitiligo AbbVie Seeks FDA, EMA Approval of RINVOQ in Vitiligo Read Post »
Clinical TrialsUCB’s BIMZELX Achieves 3-Year HS Control: BE HEARD Trial Data Reveale... UCB’s BIMZELX Achieves 3-Year HS Control: BE HEARD Trial Data Reveale... Read Post »
Clinical TrialsFDA Fast Tracks Cumberland’s Ifetroban for DMD Heart Disease FDA Fast Tracks Cumberland’s Ifetroban for DMD Heart Disease Read Post »
