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 »
New Drug ApprovalFDA Approves SKYRIZI for Children with Plaque Psoriasis and Psoriatic Arthr... FDA Approves SKYRIZI for Children with Plaque Psoriasis and Psoriatic Arthr... Read Post »
Health Tidings Mergers & AcquisitionsElixirgen and Nippon Shinyaku Partner to Advance Full-Length Dystrophin mRN... Elixirgen and Nippon Shinyaku Partner to Advance Full-Length Dystrophin mRN... Read Post »
Health TidingsFDA Schedules Advisory Committee Review of Deramiocel BLA for DMD FDA Schedules Advisory Committee Review of Deramiocel BLA for DMD Read Post »
Health TidingsFDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma Read Post »
Clinical TrialsJohnson & Johnson Reports New IMAAVY Data Supporting Early Disease Cont... Johnson & Johnson Reports New IMAAVY Data Supporting Early Disease Cont... Read Post »
Clinical TrialsCAR T-Cell Therapy Delivers 10-Year Remissions in B-Cell Lymphoma, Strength... CAR T-Cell Therapy Delivers 10-Year Remissions in B-Cell Lymphoma, Strength... Read Post »
Clinical TrialsCapricor Reports Five-Year Deramiocel Data Showing Sustained Muscle and Car... Capricor Reports Five-Year Deramiocel Data Showing Sustained Muscle and Car... Read Post »
Clinical TrialsServier to Present Three-Year OJEMDA Data and Caregiver Survey at ISPNO 202... Servier to Present Three-Year OJEMDA Data and Caregiver Survey at ISPNO 202... Read Post »
Health TidingsCHMP Backs Opzelura Cream for Moderate Atopic Dermatitis in Adults Across E... CHMP Backs Opzelura Cream for Moderate Atopic Dermatitis in Adults Across E... Read Post »
Health TidingsEMA Panel Recommends Revoking EU Approval of TAVNEOS; CSL Reaffirms Commitm... EMA Panel Recommends Revoking EU Approval of TAVNEOS; CSL Reaffirms Commitm... Read Post »
Health TidingsXspray Advances FDA Reviews of Nilopki and Dasynoc as Key Regulatory Milest... Xspray Advances FDA Reviews of Nilopki and Dasynoc as Key Regulatory Milest... Read Post »
Clinical TrialsTegoprubart Shows Superior Kidney Function to Tacrolimus in Phase 2 BESTOW ... Tegoprubart Shows Superior Kidney Function to Tacrolimus in Phase 2 BESTOW ... Read Post »
GenericsLupin Receives U.S. FDA Tentative Approval for Generic Enzalutamide Tablets Lupin Receives U.S. FDA Tentative Approval for Generic Enzalutamide Tablets Read Post »
Clinical TrialsAxsome Doses First Patient in Phase 3 FOCUS-3 Trial of Solriamfetol for Ado... Axsome Doses First Patient in Phase 3 FOCUS-3 Trial of Solriamfetol for Ado... Read Post »
Clinical TrialsGENFIT Reports Positive Results for GNS561 Combination in KRAS-Mutated Chol... GENFIT Reports Positive Results for GNS561 Combination in KRAS-Mutated Chol... Read Post »
Health Tidings Mergers & AcquisitionsMerck KGaA to Acquire Bio-Techne for $11.3 Billion to Expand Life Science P... Merck KGaA to Acquire Bio-Techne for $11.3 Billion to Expand Life Science P... Read Post »
Health TidingsRecce Raises A$4 Million to Advance R327 Trial in DFI Recce Raises A$4 Million to Advance R327 Trial in DFI Read Post »
