Clinical TrialsINmune Bio Advances XPro1595 to FDA-Aligned AD Trial INmune Bio Advances XPro1595 to FDA-Aligned AD Trial Read Post »
Health TidingsNovo Nordisk Targets Access and Flexibility with Planned Wegovy Vials Novo Nordisk Targets Access and Flexibility with Planned Wegovy Vials 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 »
Health TidingsOutlook Therapeutics Seeks FDA Type A Meeting Following CRL for LYTENAVA™... Outlook Therapeutics Seeks FDA Type A Meeting Following CRL for LYTENAVA™... Read Post »
Clinical TrialsINSIGHTT Trial Approved: Sarepta’s HD Therapy Advances INSIGHTT Trial Approved: Sarepta’s HD Therapy Advances Read Post »
Health TidingsREGENXBIO Unveils 2026 Pipeline Catalysts with Strong 18-Month DMD Trial Da... REGENXBIO Unveils 2026 Pipeline Catalysts with Strong 18-Month DMD Trial Da... Read Post »
Health TidingsDewpoint MYC Condensate Modulator Hits DC Stage Dewpoint MYC Condensate Modulator Hits DC Stage Read Post »
New Drug ApprovalKEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ Approved in Combination The... KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ Approved in Combination The... Read Post »
Health TidingsAstellas Secures $210 Million in Settlements with Lupin and Zydus Over Myrb... Astellas Secures $210 Million in Settlements with Lupin and Zydus Over Myrb... 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 »
Health Tidings Policy & AcquisitionsSanofi Closes Dynavax Deal, Expands Presence in Adult Vaccines Sanofi Closes Dynavax Deal, Expands Presence in Adult Vaccines Read Post »
Health Tidings Policy & AcquisitionsChugai Licenses Araris’ AraLinQ® Platform to Advance Next-Generation ADC... Chugai Licenses Araris’ AraLinQ® Platform to Advance Next-Generation ADC... 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 »
Health TidingsFDA Issues Refusal-to-File Letter for Moderna’s mRNA-1010 Flu Vaccine FDA Issues Refusal-to-File Letter for Moderna’s mRNA-1010 Flu Vaccine Read Post »
Clinical TrialsAstraZeneca Advances Oral GLP-1 Elecoglipron Toward Phase III AstraZeneca Advances Oral GLP-1 Elecoglipron Toward Phase III Read Post »
Food Health TidingsFDA Initiates Priority Safety Review of BHA Used in Foods FDA Initiates Priority Safety Review of BHA Used in Foods 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 »
Health TidingsIambic, Takeda Team Up on AI-Driven Small Molecule Discovery Iambic, Takeda Team Up on AI-Driven Small Molecule Discovery Read Post »
Clinical TrialsTakeda Announces FDA Acceptance of Oveporexton NDA for NT1 Takeda Announces FDA Acceptance of Oveporexton NDA for NT1 Read Post »
Health TidingsAstellas Pharma Inc. Settles U.S. Patent Litigation with Lupin Limited Over... Astellas Pharma Inc. Settles U.S. Patent Litigation with Lupin Limited Over... Read Post »
Health TidingsFDA Issues CRL for REGENXBIO’s RGX-121 in MPS II FDA Issues CRL for REGENXBIO’s RGX-121 in MPS II Read Post »
Health TidingsNovo Nordisk Files Semaglutide Lawsuit Against Hims Novo Nordisk Files Semaglutide Lawsuit Against Hims Read Post »
Policy & AcquisitionsLilly’s $2.4 Billion Orna Deal Signals Push into In Vivo CAR-T Therapies Lilly’s $2.4 Billion Orna Deal Signals Push into In Vivo CAR-T Therapies Read Post »
Clinical TrialsRoche’s Fenebrutinib Meets Phase III Endpoint in PPMS Roche’s Fenebrutinib Meets Phase III Endpoint in PPMS Read Post »
Health TidingsEisai and Biogen Secure Priority Review in China for Subcutaneous LEQEMBI Eisai and Biogen Secure Priority Review in China for Subcutaneous LEQEMBI Read Post »
Health TidingsSanofi’s Rilzabrutinib Gains FDA Breakthrough Therapy Designation, Ja... Sanofi’s Rilzabrutinib Gains FDA Breakthrough Therapy Designation, Ja... 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 »
Food Health TidingsUK Probes 36 Infant Illness Reports Linked to Recalled Infant Formula UK Probes 36 Infant Illness Reports Linked to Recalled Infant Formula Read Post »
Health TidingsFrom Launch to Halt: Hims & Hers’ Semaglutide Reversal From Launch to Halt: Hims & Hers’ Semaglutide Reversal 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 »
Health TidingsPfizer Backs TrumpRx, Reduce Drug Prices in the U.S. Pfizer Backs TrumpRx, Reduce Drug Prices in the U.S. Read Post »
Health TidingsFibrobiologics Fetches Canadian Patent for Cachexia in Chronic Diseases Fibrobiologics Fetches Canadian Patent for Cachexia in Chronic Diseases Read Post »
Health TidingsTrumpRx.gov Goes Live, Drug Pricing and Policy in One Platform TrumpRx.gov Goes Live, Drug Pricing and Policy in One Platform 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 »
Health TidingsEisai and Biogen Report Growing Real-World Use of Leqembi in Early Alzheime... Eisai and Biogen Report Growing Real-World Use of Leqembi in Early Alzheime... Read Post »
Health TidingsFDA Takes Aim at Non-Approved Compounded GLP-1 Drugs FDA Takes Aim at Non-Approved Compounded GLP-1 Drugs 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 »
Health TidingsNovo Nordisk Accuses Hims & Hers of Illegal Semaglutide Compounding, Ci... Novo Nordisk Accuses Hims & Hers of Illegal Semaglutide Compounding, Ci... 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 »
Health TidingsBMS and J&J Rethink Anticoagulation with Factor Xia BMS and J&J Rethink Anticoagulation with Factor Xia Read Post »
Health TidingsSimcere Doses First Patient in Anti-Stroke SIM0811 Trial Simcere Doses First Patient in Anti-Stroke SIM0811 Trial Read Post »
Food Policy & AcquisitionsNo to Artificial Colors, Yes to Natural Alternatives: What the New FDA Poli... No to Artificial Colors, Yes to Natural Alternatives: What the New FDA Poli... Read Post »
