Clinical TrialsTakeda’s TAK-881 delivers comparable results to HYQVIA in PID Takeda’s TAK-881 delivers comparable results to HYQVIA in PID Read Post »
Clinical TrialsNanoViricides, Inc. Secures FDA Orphan Designation for NV-387 Measles Thera... NanoViricides, Inc. Secures FDA Orphan Designation for NV-387 Measles Thera... Read Post »
Health Tidings Mergers & AcquisitionsBioCryst and Neopharmed Gentili Sign Navenibart Deal to Support 2027 Filing BioCryst and Neopharmed Gentili Sign Navenibart Deal to Support 2027 Filing Read Post »
Health TidingsMacroGenics Expands ZYNYZ Royalty Deal with Sagard, Secures Up to $80 Milli... MacroGenics Expands ZYNYZ Royalty Deal with Sagard, Secures Up to $80 Milli... Read Post »
Clinical TrialsBioMarin Highlights VOXZOGO’s Long-Term Benefits on Bone and Growth BioMarin Highlights VOXZOGO’s Long-Term Benefits on Bone and Growth Read Post »
Mergers & AcquisitionsUCB Acquires Candid Therapeutics in $2.2 Billion Autoimmune Deal UCB Acquires Candid Therapeutics in $2.2 Billion Autoimmune Deal Read Post »
ManufacturingSerum Institute Starts Development of Meiji’s Japanese Encephalitis Vacci... Serum Institute Starts Development of Meiji’s Japanese Encephalitis Vacci... Read Post »
Clinical TrialsAlector Discontinues PROGRESS-AD Trial of Nivisnebart After Futility Analys... Alector Discontinues PROGRESS-AD Trial of Nivisnebart After Futility Analys... Read Post »
Health TidingsApotex Delivers First Canadian‑Made Generic Ozempic Equivalent to Market Apotex Delivers First Canadian‑Made Generic Ozempic Equivalent to Market Read Post »
Health TidingsNeurocrine’s CRENESSITY Delivers Two-Year Hormone Control in Pediatric CA... Neurocrine’s CRENESSITY Delivers Two-Year Hormone Control in Pediatric CA... Read Post »
Health TidingsIncyte Secures FDA Nod for Jakafi XR Extended-Release Tablets Incyte Secures FDA Nod for Jakafi XR Extended-Release Tablets Read Post »
Health TidingsVanda Launches NEREUS™ (Tradipitant) in the U.S. for Motion Sickness Rela... Vanda Launches NEREUS™ (Tradipitant) in the U.S. for Motion Sickness Rela... Read Post »
ManufacturingAREXVY Gains FDA Approval for Ready-to-Use Vial and Prefilled Syringe AREXVY Gains FDA Approval for Ready-to-Use Vial and Prefilled Syringe Read Post »
New Drug ApprovalFDA Clears VEPPANU, First PROTAC Therapy, for Advanced Breast Cancer FDA Clears VEPPANU, First PROTAC Therapy, for Advanced Breast Cancer Read Post »
Health TidingsRevolution Medicines Secures FDA Expanded Access for Daraxonrasib in PDAC Revolution Medicines Secures FDA Expanded Access for Daraxonrasib in PDAC Read Post »
New Drug ApprovalMHRA Clears Linerixibat (Lynavoy) for PBC-Related Itch in Adults MHRA Clears Linerixibat (Lynavoy) for PBC-Related Itch in Adults Read Post »
New Drug ApprovalJohnson & Johnson Secures FDA Nod for STELARA in Pediatric Crohn’s Johnson & Johnson Secures FDA Nod for STELARA in Pediatric Crohn’s Read Post »
Drugs Safety AlertMHRA Sets 5-Day Limit on OTC Nasal Decongestant Sprays MHRA Sets 5-Day Limit on OTC Nasal Decongestant Sprays Read Post »
New Drug ApprovalRhythm Wins EU Approval for IMCIVREE in Acquired Hypothalamic Obesity Rhythm Wins EU Approval for IMCIVREE in Acquired Hypothalamic Obesity Read Post »
New Drug ApprovalArrowhead Breaks the Triglyceride Barrier with REDEMPLO Approval in Austral... Arrowhead Breaks the Triglyceride Barrier with REDEMPLO Approval in Austral... Read Post »
Clinical TrialsCorcept Drives Survival Gain in ALS Despite Missing Primary Endpoint Corcept Drives Survival Gain in ALS Despite Missing Primary Endpoint Read Post »
Health Tidings Mergers & AcquisitionsUCB Taps IMIDomics to Power Its Precision Medicine Engine UCB Taps IMIDomics to Power Its Precision Medicine Engine Read Post »
Health TidingsFDA Panel Votes Against AstraZeneca’s Camizestrant Combo FDA Panel Votes Against AstraZeneca’s Camizestrant Combo Read Post »
Regulatory & Health PolicyFDA Acts to Restrict Compounding of Popular GLP-1 Therapies from Bulk Subst... FDA Acts to Restrict Compounding of Popular GLP-1 Therapies from Bulk Subst... Read Post »
Health TidingsAstraZeneca Reports Positive FDA Panel Vote for Truqap Combination AstraZeneca Reports Positive FDA Panel Vote for Truqap Combination Read Post »
New Drug ApprovalAxsome Wins FDA Decision for Auvelity in Alzheimer’s Agitation Axsome Wins FDA Decision for Auvelity in Alzheimer’s Agitation Read Post »
Health TidingsJohnson & Johnson Discontinues CD20 and CD19–CD20 CAR-Tv Programs in ... Johnson & Johnson Discontinues CD20 and CD19–CD20 CAR-Tv Programs in ... Read Post »
New Drug ApprovalNorgine Pushes the Frontier of WHIM Treatment With XOLREMDI EU Approval Norgine Pushes the Frontier of WHIM Treatment With XOLREMDI EU Approval Read Post »
Clinical TrialsTelix Advances TLX597-Tx with Positive Phase 2 Dosimetry Findings Telix Advances TLX597-Tx with Positive Phase 2 Dosimetry Findings Read Post »
New Drug ApprovalMitsubishi Tanabe Brings Steady Control to Parkinson’s with EU Nod for On... Mitsubishi Tanabe Brings Steady Control to Parkinson’s with EU Nod for On... Read Post »
Health TidingsuniQure Moves Toward UK Approval Filing for AMT-130 in Huntington’s Disea... uniQure Moves Toward UK Approval Filing for AMT-130 in Huntington’s Disea... Read Post »
Health TidingsInsilico Medicine Advances AI-Developed Rentosertib into Inhalation Trial Insilico Medicine Advances AI-Developed Rentosertib into Inhalation Trial Read Post »
Health TidingsBayer Files Asundexian in China for Secondary Stroke Prevention Bayer Files Asundexian in China for Secondary Stroke Prevention Read Post »
Health TidingsBiogen and Eisai Strengthen LEQEMBI’s Role in Alzheimer’s Treatment Biogen and Eisai Strengthen LEQEMBI’s Role in Alzheimer’s Treatment Read Post »
Regulatory & Health PolicyNICE Recommends Rozanolixizumab as New Option for Uncontrolled gMG NICE Recommends Rozanolixizumab as New Option for Uncontrolled gMG Read Post »
Clinical TrialsNovo Nordisk Strikes at the Core of Haemophilia A with Denecimig Breakthrou... Novo Nordisk Strikes at the Core of Haemophilia A with Denecimig Breakthrou... Read Post »
Mergers & AcquisitionsChiesi Seals a Strategic Win with $1.9B KalVista Acquisition Chiesi Seals a Strategic Win with $1.9B KalVista Acquisition Read Post »
Clinical TrialsNewron Hits a Regulatory Speed Bump as FDA Pauses U.S. Enrollment in ENIGMA... Newron Hits a Regulatory Speed Bump as FDA Pauses U.S. Enrollment in ENIGMA... Read Post »
Food Health Tidings Regulatory & Health PolicyWhy FDA’s Infant Formula Findings Reassure, Yet Call for Vigilance Why FDA’s Infant Formula Findings Reassure, Yet Call for Vigilance Read Post »
Clinical TrialsVeradermics Meets Endpoints with Oral VDPHL01 in Pattern Hair Loss Study Veradermics Meets Endpoints with Oral VDPHL01 in Pattern Hair Loss Study Read Post »
Clinical TrialsGilead Leverages Priority Review to Advance Bic/Len in HIV Care Gilead Leverages Priority Review to Advance Bic/Len in HIV Care Read Post »
Health TidingsBeOne Gains Ground in GEA as FDA Fast-Tracks TEVIMBRA Combo BeOne Gains Ground in GEA as FDA Fast-Tracks TEVIMBRA Combo Read Post »
Clinical TrialsPfizer Sets a New Pace in Multiple Myeloma Treatment with ELREXFIO Pfizer Sets a New Pace in Multiple Myeloma Treatment with ELREXFIO Read Post »
Clinical TrialsImmunome Reports Strong Phase 3 Data, Submits NDA for Varegacestat Immunome Reports Strong Phase 3 Data, Submits NDA for Varegacestat Read Post »
Mergers & AcquisitionsTeva to Acquire Emalex and Add Tourette Drug Ecopipam Teva to Acquire Emalex and Add Tourette Drug Ecopipam Read Post »
Clinical TrialsFDA Real-Time Trials: AstraZeneca and Amgen Lead Breakthrough FDA Real-Time Trials: AstraZeneca and Amgen Lead Breakthrough Read Post »
Mergers & AcquisitionsProfluent and Eli Lilly Chase the ‘Holy Grail’ of DNA Editing Profluent and Eli Lilly Chase the ‘Holy Grail’ of DNA Editing Read Post »
Health TidingsPfizer Extends U.S. Patent Protection for Tafamidis Drug VYNDAMAX to 2031 Pfizer Extends U.S. Patent Protection for Tafamidis Drug VYNDAMAX to 2031 Read Post »
Health Tidings Regulatory & Health PolicyMHRA and FDA Drive Changes to Improve Trial Efficiency MHRA and FDA Drive Changes to Improve Trial Efficiency Read Post »
Health TidingsQUVIVIQ Powers Idorsia Growth with Strong Sales and Expanding Clinical Evid... QUVIVIQ Powers Idorsia Growth with Strong Sales and Expanding Clinical Evid... Read Post »
