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 »
Clinical TrialsAstellas Fezolinetant Cuts Menopausal VMS in Japan Phase 3 Astellas Fezolinetant Cuts Menopausal VMS in Japan Phase 3 Read Post »
Clinical TrialsImmunityBio Launches Phase 2 ResQ215B Trial for Indolent B-Cell Lymphoma ImmunityBio Launches Phase 2 ResQ215B Trial for Indolent B-Cell Lymphoma Read Post »
ResearchJohnson & Johnson Calls Out Surgeon Mental Health Crisis Johnson & Johnson Calls Out Surgeon Mental Health Crisis Read Post »
Clinical TrialsNovo Nordisk’s CagriSema Outperforms Semaglutide in REIMAGINE 2 Trial Novo Nordisk’s CagriSema Outperforms Semaglutide in REIMAGINE 2 Trial Read Post »
New Drug ApprovalBayer’s Nubeqa Approved for mHSPC in China Bayer’s Nubeqa Approved for mHSPC in China Read Post »
Clinical TrialsPfizer Bets Big on Monthly GLP-1 After Metsera Deal, VESPER-3 Hits Key Endp... Pfizer Bets Big on Monthly GLP-1 After Metsera Deal, VESPER-3 Hits Key Endp... Read Post »
Clinical TrialsJohnson & Johnson Unveils Real-World Data: ERLEADA Cuts Death Risk by 5... Johnson & Johnson Unveils Real-World Data: ERLEADA Cuts Death Risk by 5... Read Post »
Clinical TrialsPositive Topline Results: Venglustat Succeeds in Sanofi’s LEAP2MONO GD3 S... Positive Topline Results: Venglustat Succeeds in Sanofi’s LEAP2MONO GD3 S... Read Post »
New Drug ApprovalImfinzi Boosts Survival in Gastric Cancer, Gains CHMP Endorsement Imfinzi Boosts Survival in Gastric Cancer, Gains CHMP Endorsement Read Post »
Clinical TrialsLundbeck INFUSE Study: Vyepti Shines for Hard-to-Treat Migraine Lundbeck INFUSE Study: Vyepti Shines for Hard-to-Treat Migraine Read Post »
New Drug ApprovalCHMP Backs Rezurock for Chronic GVHD After Re-Examination CHMP Backs Rezurock for Chronic GVHD After Re-Examination Read Post »
New Drug ApprovalIncyte’s Zynyz Wins Positive CHMP Opinion in Advanced Anal Cancer Incyte’s Zynyz Wins Positive CHMP Opinion in Advanced Anal Cancer Read Post »
ResearchMigraine Attacks Disrupt Relationships, AbbVie Report Migraine Attacks Disrupt Relationships, AbbVie Report Read Post »
New Drug ApprovalEMA CHMP Recommends Bayer’s Finerenone for Heart Failure with LVEF â‰... EMA CHMP Recommends Bayer’s Finerenone for Heart Failure with LVEF â‰... Read Post »
New Drug ApprovalJ&J Scores CHMP Nod for AKEEGA in High-Risk Prostate Cancer J&J Scores CHMP Nod for AKEEGA in High-Risk Prostate Cancer Read Post »
New Drug ApprovalFDA Approves Tenpoint’s YUVEZZI Eye Drop for Presbyopia Treatment FDA Approves Tenpoint’s YUVEZZI Eye Drop for Presbyopia Treatment Read Post »
Clinical TrialsUltragenyx Resubmits BLA for UX111 Gene Therapy in Sanfilippo Syndrome Type... Ultragenyx Resubmits BLA for UX111 Gene Therapy in Sanfilippo Syndrome Type... Read Post »
Clinical TrialsTanabe Pharma’s ZYNLONTA® Hits Key Endpoint in Japanese r/r DLBCL Tr... Tanabe Pharma’s ZYNLONTA® Hits Key Endpoint in Japanese r/r DLBCL Tr... Read Post »
Clinical TrialsFDA Grants Class II Review for Unicycive’s Resubmission of OLC in Hyperph... FDA Grants Class II Review for Unicycive’s Resubmission of OLC in Hyperph... Read Post »
Drugs Safety AlertFDA Halts REGENXBIO’s RGX-111 and RGX-121 After CNS Tumor Case FDA Halts REGENXBIO’s RGX-111 and RGX-121 After CNS Tumor Case Read Post »
