Clinical TrailsUltragenyx 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 »
FoodDaily Coffee and Tea Habits Associated With Reduced Dementia Risk Daily Coffee and Tea Habits Associated With Reduced Dementia Risk Read Post »
Health TidingsOno Pharmaceutical’s Tirabrutinib NDA Accepted by FDA for R/R PCNSL Ono Pharmaceutical’s Tirabrutinib NDA Accepted by FDA for R/R PCNSL Read Post »
Health TidingsLilly’s Retevmo Improves Event-Free Survival in Early RET+ NSCLC Lilly’s Retevmo Improves Event-Free Survival in Early RET+ NSCLC Read Post »
Health TidingsNeedle-Free neffy: Launches in Australia for Anaphylaxis Needle-Free neffy: Launches in Australia for Anaphylaxis Read Post »
Health TidingsEisai Secures Orphan Drug Designation in Japan for E2086 in Narcolepsy Eisai Secures Orphan Drug Designation in Japan for E2086 in Narcolepsy Read Post »
Clinical TrailsRoche’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 TrailsSanofi’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Drugs Safety AlertLevamisole to be Withdrawn from EU Market Over Leukoencephalopathy Risk Levamisole to be Withdrawn from EU Market Over Leukoencephalopathy Risk Read Post »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 »
Health TidingsOtsuka’s REXULTI Added to Japan’s Disaster Essential Medicines List Otsuka’s REXULTI Added to Japan’s Disaster Essential Medicines List Read Post »
Health TidingsDisc Medicine Gets FDA CRL for Bitopertin, Eyes APOLLO Trial Disc Medicine Gets FDA CRL for Bitopertin, Eyes APOLLO Trial Read Post »
Clinical TrailsNovartis 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 TrailsAstraZeneca Breztri Boosts FEV1 in Asthma Trials AstraZeneca Breztri Boosts FEV1 in Asthma Trials Read Post »
Clinical TrailsLundbeck Reports Positive Phase IIb Results for Bocunebart in Migraine Lundbeck Reports Positive Phase IIb Results for Bocunebart in Migraine Read Post »
Health TidingsPTC Pulls Ataluren NDA for nmDMD After FDA Review Feedback PTC Pulls Ataluren NDA for nmDMD After FDA Review Feedback Read Post »
Health TidingsINmune Bio Files MHRA Pre-Submission for CORDStrom in RDEB INmune Bio Files MHRA Pre-Submission for CORDStrom in RDEB Read Post »
Clinical TrailsINmune 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 TrailsBridgeBio’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 TrailsINSIGHTT 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 TrailsFDA 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 Trails 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 TrailsGSK’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 TrailsAstraZeneca 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 TrailsKyowa 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 TrailsTakeda 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 TrailsRoche’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 »
