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 »
Health TidingsFDA Grants Fast Track to Amyloid-Depleting Antibody Coramitug for ATTR-CM FDA Grants Fast Track to Amyloid-Depleting Antibody Coramitug for ATTR-CM Read Post »
Health TidingsGSK advances bepirovirsen with FDA priority review in hepatitis B GSK advances bepirovirsen with FDA priority review in hepatitis B Read Post »
Health TidingsFDA Takes Up Zipalertinib Application for Lung Cancer FDA Takes Up Zipalertinib Application for Lung Cancer Read Post »
New Drug ApprovalAstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... AstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... Read Post »
Clinical TrialsBoehringer’s survodutide Achieves Up to 16.6% Weight Loss in Phase II... Boehringer’s survodutide Achieves Up to 16.6% Weight Loss in Phase II... Read Post »
Clinical TrialsAbbVie Files Upadacitinib for FDA Approval in Alopecia Areata AbbVie Files Upadacitinib for FDA Approval in Alopecia Areata Read Post »
Health TidingsJanux discontinues JANX008 after Phase 1a results over efficacy Janux discontinues JANX008 after Phase 1a results over efficacy Read Post »
Health TidingsGilead Completes $7.8 Billion Acquisition of Arcellx, Gains Full Control of... Gilead Completes $7.8 Billion Acquisition of Arcellx, Gains Full Control of... Read Post »
Health TidingsTerns Advances TERN-701 with FDA Breakthrough Therapy Designation in CML Terns Advances TERN-701 with FDA Breakthrough Therapy Designation in CML Read Post »
Clinical TrialsMundipharma Positions REZZAYO as a Steady Shield in Fungal Prevention Study Mundipharma Positions REZZAYO as a Steady Shield in Fungal Prevention Study Read Post »
Health TidingsFDA Seeks to Withdraw TAVNEOS After Identifying Efficacy Gaps FDA Seeks to Withdraw TAVNEOS After Identifying Efficacy Gaps Read Post »
Clinical TrialsOruka Therapeutics Reports Strong 16-Week Results for ORKA-001 in Psoriasis Oruka Therapeutics Reports Strong 16-Week Results for ORKA-001 in Psoriasis Read Post »
