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 »
Health TidingsMHRA Validates Eisai’s Taletrectinib for ROS1-Positive Lung Cancer MHRA Validates Eisai’s Taletrectinib for ROS1-Positive Lung Cancer Read Post »
Health Tidings Mergers & AcquisitionsNovartis Partners With Antares in Up to $1.9 Billion Oncology Drug Deal Novartis Partners With Antares in Up to $1.9 Billion Oncology Drug Deal Read Post »
Health TidingsMHRA Approves Pediatric Investigation Plan for Ebstrocel in RDEB MHRA Approves Pediatric Investigation Plan for Ebstrocel in RDEB Read Post »
New Drug ApprovalFDA Approves KEYTRUDA Plus Trodelvy for First-Line Advanced Triple-Negative... FDA Approves KEYTRUDA Plus Trodelvy for First-Line Advanced Triple-Negative... Read Post »
Clinical TrialsCentanafadine Improves ADHD and Anxiety Symptoms in Phase 3b Trial Ahead of... Centanafadine Improves ADHD and Anxiety Symptoms in Phase 3b Trial Ahead of... Read Post »
Health Tidings Mergers & AcquisitionsIonis Partners with Recordati to Commercialize Zilganersen for Alexander Di... Ionis Partners with Recordati to Commercialize Zilganersen for Alexander Di... Read Post »
Clinical TrialsCeleCor Submits NDA for Zalunfiban After Positive CeleBrate Trial Results CeleCor Submits NDA for Zalunfiban After Positive CeleBrate Trial Results Read Post »
Clinical TrialsHUTCHMED Reports Positive Results for Fanregratinib in FGFR2-Altered Intrah... HUTCHMED Reports Positive Results for Fanregratinib in FGFR2-Altered Intrah... Read Post »
Clinical TrialsAvacta Reports Positive Data for Faridoxorubicin in Salivary Gland Cancer Avacta Reports Positive Data for Faridoxorubicin in Salivary Gland Cancer Read Post »
Health TidingsOllin Raises $330 Million to Advance Phase 3 Trials of VEGF/Ang2 Bispecific... Ollin Raises $330 Million to Advance Phase 3 Trials of VEGF/Ang2 Bispecific... Read Post »
Health Tidings Mergers & AcquisitionsEli Lilly Expands Abbisko Alliance in Up to $1.9 Billion Multi-Target Drug ... Eli Lilly Expands Abbisko Alliance in Up to $1.9 Billion Multi-Target Drug ... Read Post »
New Drug ApprovalTrodelvy Wins FDA Approval for First-Line mTNBC After EU Approval Trodelvy Wins FDA Approval for First-Line mTNBC After EU Approval Read Post »
New Drug ApprovalFDA Approves IBRANCE for HR+/HER2+ Metastatic Breast Cancer FDA Approves IBRANCE for HR+/HER2+ Metastatic Breast Cancer Read Post »
New Drug ApprovalFDA Approves TRYNGOLZA (Olezarsen) to Reduce Triglycerides and Acute Pancre... FDA Approves TRYNGOLZA (Olezarsen) to Reduce Triglycerides and Acute Pancre... Read Post »
Health TidingsFDA Converts Tecelra to Full Approval, Broadens Label to Adolescents FDA Converts Tecelra to Full Approval, Broadens Label to Adolescents Read Post »
Health TidingsADC Therapeutics Cuts Workforce by 17% to Support ZYNLONTA Regulatory Expan... ADC Therapeutics Cuts Workforce by 17% to Support ZYNLONTA Regulatory Expan... Read Post »
Health TidingsFDA Clears Phase 3 Path for Entera’s Oral Osteoporosis Therapy EB613 FDA Clears Phase 3 Path for Entera’s Oral Osteoporosis Therapy EB613 Read Post »
Clinical TrialsCognition Aligns with FDA on Phase 3 Pathway for Zervimesine in Dementia wi... Cognition Aligns with FDA on Phase 3 Pathway for Zervimesine in Dementia wi... Read Post »
Clinical TrialsREGENXBIO Completes RGX-202 Confirmatory Study Enrollment, Advances Duchenn... REGENXBIO Completes RGX-202 Confirmatory Study Enrollment, Advances Duchenn... Read Post »
Health TidingsNICE Recommends Cemiplimab for Recurrent or Metastatic Cervical Cancer on t... NICE Recommends Cemiplimab for Recurrent or Metastatic Cervical Cancer on t... Read Post »
Clinical TrialsAbsci Reports Positive Phase 1 Interim Data for ABS-201, Advances Novel Hai... Absci Reports Positive Phase 1 Interim Data for ABS-201, Advances Novel Hai... Read Post »
Health Tidings Mergers & AcquisitionsNuvectis Adds Late-Stage NXP100 and NXP200 in Haisco Licensing Deal Nuvectis Adds Late-Stage NXP100 and NXP200 in Haisco Licensing Deal Read Post »
New Drug ApprovalPADCEV Plus Keytruda Wins EU Approval for Cisplatin-Ineligible MIBC PADCEV Plus Keytruda Wins EU Approval for Cisplatin-Ineligible MIBC Read Post »
GenericsFDA Approves First Generic Rifapentine Tablets for Active and Latent Tuberc... FDA Approves First Generic Rifapentine Tablets for Active and Latent Tuberc... Read Post »
Health TidingsFDA Modernizes Clinical Research Through Operation TrialBlazer FDA Modernizes Clinical Research Through Operation TrialBlazer Read Post »
Health TidingsBreakthrough T1D Backs MannKind’s INHALE-1ST Trial of Afrezza in Newly Di... Breakthrough T1D Backs MannKind’s INHALE-1ST Trial of Afrezza in Newly Di... Read Post »
Clinical TrialsVerastem Reports Encouraging Phase 1/2 Results for KRAS G12D Inhibitor VS-7... Verastem Reports Encouraging Phase 1/2 Results for KRAS G12D Inhibitor VS-7... Read Post »
New Drug ApprovalSanofi’s Wayrilz Wins Japan Approval for Chronic Immune Thrombocytopenia Sanofi’s Wayrilz Wins Japan Approval for Chronic Immune Thrombocytopenia Read Post »
Health TidingsGondolaBio Reports Positive Phase 2a Results for PORT-77 in EPP GondolaBio Reports Positive Phase 2a Results for PORT-77 in EPP Read Post »
New Drug ApprovalEU Authorizes MAVIRET for Adults and Children with Acute Hepatitis C EU Authorizes MAVIRET for Adults and Children with Acute Hepatitis C Read Post »
Clinical TrialsRevMed Advances Zoldonrasib into Phase 3 Pancreatic Cancer Trial RevMed Advances Zoldonrasib into Phase 3 Pancreatic Cancer Trial Read Post »
Health TidingsFDA Agrees on Phase 3 Plan for Galectin’s Belapectin in MASH Cirrhosi... FDA Agrees on Phase 3 Plan for Galectin’s Belapectin in MASH Cirrhosi... Read Post »
Health TidingsIMUNON Reports Positive Safety Review for Phase 3 IMNN-001 Ovarian Cancer S... IMUNON Reports Positive Safety Review for Phase 3 IMNN-001 Ovarian Cancer S... Read Post »
