New Drug ApprovalFDA Approves CASGEVY for Children Aged 2 and Older With SCD and TDT FDA Approves CASGEVY for Children Aged 2 and Older With SCD and TDT Read Post »
Health TidingsTelix Secures FDA Alignment to Advance ProstACT Global Trial of TLX591-Tx i... Telix Secures FDA Alignment to Advance ProstACT Global Trial of TLX591-Tx i... Read Post »
Clinical TrialsGlenmark Advances Global Phase 3 Trial of Trastuzumab Rezetecan in Platinum... Glenmark Advances Global Phase 3 Trial of Trastuzumab Rezetecan in Platinum... Read Post »
Clinical TrialsVOYXACT Becomes First APRIL Inhibitor to Stabilize eGFR in Phase 3 VISIONAR... VOYXACT Becomes First APRIL Inhibitor to Stabilize eGFR in Phase 3 VISIONAR... Read Post »
GenericsSamsung Bioepis Relaunches BYOOVIZ® in the US Through Harrow Partnership Samsung Bioepis Relaunches BYOOVIZ® in the US Through Harrow Partnership Read Post »
Health TidingsTerrestrial Begins First-in-Human Trial of Needle-Free Semaglutide Microarr... Terrestrial Begins First-in-Human Trial of Needle-Free Semaglutide Microarr... Read Post »
Health Tidings Mergers & AcquisitionsIpsen Acquires Memo Therapeutics, Adds Potravitug to Rare Disease Pipeline Ipsen Acquires Memo Therapeutics, Adds Potravitug to Rare Disease Pipeline Read Post »
Health TidingsGalderma Receives FDA Complete Response Letter for Relfydess BLA; Manufactu... Galderma Receives FDA Complete Response Letter for Relfydess BLA; Manufactu... Read Post »
Clinical TrialsCan-Fite Reports Durable Survival with Namodenoson in Heavily Pretreated Pa... Can-Fite Reports Durable Survival with Namodenoson in Heavily Pretreated Pa... Read Post »
Clinical TrialsNew ITC Analyses Support Overall Survival Benefit of Mogamulizumab in CTCL New ITC Analyses Support Overall Survival Benefit of Mogamulizumab in CTCL Read Post »
Health TidingsKowa Submits FDA NDA for Nicox’s NCX 470 in Open-Angle Glaucoma and O... Kowa Submits FDA NDA for Nicox’s NCX 470 in Open-Angle Glaucoma and O... Read Post »
Health TidingsMesoblast Files FDA BLA for Rexlemestrocel-L to Prevent GI Bleeding in LVAD... Mesoblast Files FDA BLA for Rexlemestrocel-L to Prevent GI Bleeding in LVAD... Read Post »
Health TidingsAzurity Acquires CONTRAVE to Expand into Obesity Treatment Azurity Acquires CONTRAVE to Expand into Obesity Treatment Read Post »
Health TidingsFDA Approves Orca Bio’s TREGZI to Improve Chronic GVHD-Free Survival ... FDA Approves Orca Bio’s TREGZI to Improve Chronic GVHD-Free Survival ... Read Post »
Clinical TrialsBeOne’s BRUKINSA Plus Rituximab Cuts Progression Risk by 43% in First-Lin... BeOne’s BRUKINSA Plus Rituximab Cuts Progression Risk by 43% in First-Lin... Read Post »
Clinical TrialsSkyhawk Reports Positive 12-Month Phase 1/2 SKY-0515 Data in HuntingtonR... Skyhawk Reports Positive 12-Month Phase 1/2 SKY-0515 Data in HuntingtonR... Read Post »
Clinical TrialsSanofi’s Nexviazyme Meets All Endpoints in Phase 3 Baby-COMET Study for I... Sanofi’s Nexviazyme Meets All Endpoints in Phase 3 Baby-COMET Study for I... Read Post »
Clinical TrialsAkebia Ends VOICE Trial Early as Vafseo Shows Superior Safety Over ESAs Akebia Ends VOICE Trial Early as Vafseo Shows Superior Safety Over ESAs Read Post »
Health TidingsSarepta’s Duchenne Drugs AMONDYS 45 and VYONDYS 53 Advance Toward Full FD... Sarepta’s Duchenne Drugs AMONDYS 45 and VYONDYS 53 Advance Toward Full FD... Read Post »
Health TidingsFDA Issues Second CRL for Unicycive’s Oxylanthanum Carbonate NDA FDA Issues Second CRL for Unicycive’s Oxylanthanum Carbonate NDA Read Post »
Clinical TrialsVistagen Eyes New Registration Strategy After Fasedienol Phase 3 Miss Vistagen Eyes New Registration Strategy After Fasedienol Phase 3 Miss Read Post »
Clinical TrialsAscendis’s TransCon CNP Improved Leg Alignment Through Two Years in C... Ascendis’s TransCon CNP Improved Leg Alignment Through Two Years in C... Read Post »
Health TidingsCogent Biosciences Submits NDA for Bezuclastinib in Advanced Systemic Masto... Cogent Biosciences Submits NDA for Bezuclastinib in Advanced Systemic Masto... Read Post »
Health TidingsFDA Grants Three-Month Review Extension for Relutrigine NDA FDA Grants Three-Month Review Extension for Relutrigine NDA Read Post »
Clinical TrialsAbivax Reports Positive Phase 3 Maintenance Data for Obefazimod in Refracto... Abivax Reports Positive Phase 3 Maintenance Data for Obefazimod in Refracto... Read Post »
Health Tidings Mergers & AcquisitionsInnovent Secures Exclusive China Rights to Lilly’s Verzenios Innovent Secures Exclusive China Rights to Lilly’s Verzenios Read Post »
Health TidingsREGENXBIO Initiates Phase IIb/III NAAVIGATE Trial of Sura-Vec for Diabetic ... REGENXBIO Initiates Phase IIb/III NAAVIGATE Trial of Sura-Vec for Diabetic ... Read Post »
Health TidingsFDA Accepts Roche’s Enspryng sBLA Under Priority Review for TED FDA Accepts Roche’s Enspryng sBLA Under Priority Review for TED Read Post »
New Drug ApprovalFDA Expands ZORYVE Cream Approval to Children as Young as 2 Years with Plaq... FDA Expands ZORYVE Cream Approval to Children as Young as 2 Years with Plaq... Read Post »
Clinical TrialsEVO756 Fails Phase 2b CSU Trial, Evommune Shifts Focus to Atopic Dermatitis... EVO756 Fails Phase 2b CSU Trial, Evommune Shifts Focus to Atopic Dermatitis... Read Post »
Clinical TrialsAbbVie Phase 3 Trial Shows Epcoritamab Combination Significantly Extends Pr... AbbVie Phase 3 Trial Shows Epcoritamab Combination Significantly Extends Pr... Read Post »
Clinical TrialsViatris Reports Positive Phase 3 Results for VR-205 in Japanese IgA Nephrop... Viatris Reports Positive Phase 3 Results for VR-205 in Japanese IgA Nephrop... Read Post »
Clinical TrialsGrünenthal Moves NOP Agonist into Phase II After Positive Phase I Results Grünenthal Moves NOP Agonist into Phase II After Positive Phase I Results Read Post »
Health TidingsBioCryst Ends Internal Discovery Efforts, Strengthens Focus on Clinical-Sta... BioCryst Ends Internal Discovery Efforts, Strengthens Focus on Clinical-Sta... Read Post »
Clinical TrialsAvecho Advances Phase III CBD Insomnia Trial After Positive Interim Review ... Avecho Advances Phase III CBD Insomnia Trial After Positive Interim Review ... Read Post »
Health TidingsBiohaven Starts Pivotal Phase 3 Trial of BHV-1300, the First Extracellular ... Biohaven Starts Pivotal Phase 3 Trial of BHV-1300, the First Extracellular ... Read Post »
Health TidingsCHMP Backs Hopledo for Parkinson’s Following Positive RISE-PD Results CHMP Backs Hopledo for Parkinson’s Following Positive RISE-PD Results Read Post »
Clinical TrialsSamsung Bioepis Reports Positive Clinical Results for Pembrolizumab Biosimi... Samsung Bioepis Reports Positive Clinical Results for Pembrolizumab Biosimi... Read Post »
Health Tidings Mergers & AcquisitionsIpsen to Acquire Kartos Therapeutics in Up to $1.75B Deal, Adds Myelofibros... Ipsen to Acquire Kartos Therapeutics in Up to $1.75B Deal, Adds Myelofibros... Read Post »
New Drug ApprovalEU Approves Enhertu as First HER2 Tumor-Agnostic Therapy for Advanced Solid... EU Approves Enhertu as First HER2 Tumor-Agnostic Therapy for Advanced Solid... Read Post »
Clinical TrialsOral Infigratinib Phase 3 PROPEL 3 Results Published in NEJM, Adding New Ar... Oral Infigratinib Phase 3 PROPEL 3 Results Published in NEJM, Adding New Ar... Read Post »
Clinical TrialsAstra Zeneca’s Efzimfotase Alfa Improves Bone Health in Hypophosphata... Astra Zeneca’s Efzimfotase Alfa Improves Bone Health in Hypophosphata... Read Post »
Clinical TrialsEpicrispr’s EPI-321 Shows Early Muscle Gain and Favorable Safety in First... Epicrispr’s EPI-321 Shows Early Muscle Gain and Favorable Safety in First... Read Post »
Health TidingsFDA Issues Complete Response Letter for Sobi’s NASP in Uncontrolled G... FDA Issues Complete Response Letter for Sobi’s NASP in Uncontrolled G... Read Post »
Clinical TrialsHemab Reports Positive Early Data for HMB-002 in Von Willebrand Disease, Ad... Hemab Reports Positive Early Data for HMB-002 in Von Willebrand Disease, Ad... Read Post »
Health TidingsModerna Highlights Expanding mRNA Pipeline Beyond Vaccines with Oncology Moderna Highlights Expanding mRNA Pipeline Beyond Vaccines with Oncology Read Post »
Clinical TrialsCumberland Reports New Biomarker Data Supporting Ifetroban’s Heart-Pr... Cumberland Reports New Biomarker Data Supporting Ifetroban’s Heart-Pr... Read Post »
Health TidingsEMA CHMP Issues Negative Opinion on Narsoplimab for TA-TMA; Omeros to Seek ... EMA CHMP Issues Negative Opinion on Narsoplimab for TA-TMA; Omeros to Seek ... Read Post »
Health TidingsFDA Issues Complete Response Letter for Lantheus’ LNTH-2501 PET Imagi... FDA Issues Complete Response Letter for Lantheus’ LNTH-2501 PET Imagi... Read Post »
New Drug ApprovalFDA Approves Veligrotug as First Treatment for Active and Chronic Thyroid E... FDA Approves Veligrotug as First Treatment for Active and Chronic Thyroid E... Read Post »
