Health TidingsServier’s Emi-Le Receives FDA Breakthrough Therapy Designation for Adenoi... Servier’s Emi-Le Receives FDA Breakthrough Therapy Designation for Adenoi... Read Post »
ManufacturingMacroGenics Hands Bora the Keys to Its Maryland Manufacturing Engine MacroGenics Hands Bora the Keys to Its Maryland Manufacturing Engine Read Post »
Health Tidings Mergers & AcquisitionsBMS and Hengrui Forge a $15.2 Billion Drug Discovery Alliance BMS and Hengrui Forge a $15.2 Billion Drug Discovery Alliance Read Post »
GenericsTranspire Stakes Its Claim in the Generic Trelegy Ellipta Race Transpire Stakes Its Claim in the Generic Trelegy Ellipta Race Read Post »
Health Tidings Mergers & AcquisitionsGSK Aligns With CTTQ to Expand Access to Bepirovirsen in China GSK Aligns With CTTQ to Expand Access to Bepirovirsen in China Read Post »
Health Tidings Mergers & AcquisitionsOncotelic-Lunai N2B Deal Gains Momentum Amid Rising Focus on CNS Drug Deliv... Oncotelic-Lunai N2B Deal Gains Momentum Amid Rising Focus on CNS Drug Deliv... Read Post »
Health TidingsZai Lab Puts Zoci on the Fast Track in the Race Against epNEC Zai Lab Puts Zoci on the Fast Track in the Race Against epNEC Read Post »
Health TidingsInnovent Biologics Moves IBI363 Into Phase III After China Breakthrough Nod Innovent Biologics Moves IBI363 Into Phase III After China Breakthrough Nod Read Post »
Health TidingsMoonLake Aligns with FDA on BLA Strategy for SLK in Hidradenitis Suppurativ... MoonLake Aligns with FDA on BLA Strategy for SLK in Hidradenitis Suppurativ... Read Post »
Health TidingsServier and Day One Complete Enrollment in Phase 3 OJEMDA Glioma Trial Servier and Day One Complete Enrollment in Phase 3 OJEMDA Glioma Trial Read Post »
Health TidingsCapricor Files Lawsuit Against NS Pharma Over Deramiocel Access Capricor Files Lawsuit Against NS Pharma Over Deramiocel Access Read Post »
Health TidingsEisai and Biogen Face Three-Month FDA Delay for LEQEMBI sBLA Eisai and Biogen Face Three-Month FDA Delay for LEQEMBI sBLA Read Post »
Health TidingsAtara and Pierre Fabre Aligns with FDA on Tab-cel BLA Resubmission Path Atara and Pierre Fabre Aligns with FDA on Tab-cel BLA Resubmission Path Read Post »
Health TidingsBayer Wins China Priority Review for Asundexian in Stroke Prevention Bayer Wins China Priority Review for Asundexian in Stroke Prevention Read Post »
Health TidingsAvalo Reports Positive Phase 2 Results for Abdakibart in HS Avalo Reports Positive Phase 2 Results for Abdakibart in HS Read Post »
Health TidingsBIZENGRI Receives FDA Priority Voucher in NRG1+ Cholangiocarcinoma BIZENGRI Receives FDA Priority Voucher in NRG1+ Cholangiocarcinoma Read Post »
Health Tidings Mergers & AcquisitionsGSK Partners With Halozyme to Develop Subcutaneous ADC Therapies GSK Partners With Halozyme to Develop Subcutaneous ADC Therapies Read Post »
Health TidingsMHRA Intensifies Operation Pangea Crackdown on Illegal Medicines MHRA Intensifies Operation Pangea Crackdown on Illegal Medicines Read Post »
Health Tidings Mergers & AcquisitionsGSK Licenses SiranBio’s siRNA Candidate SA030 in Up to $1 Billion Deal GSK Licenses SiranBio’s siRNA Candidate SA030 in Up to $1 Billion Deal Read Post »
Health Tidings Mergers & AcquisitionsBayer to Acquire Perfuse Therapeutics in Up to USD 2.45 Billion Ophthalmolo... Bayer to Acquire Perfuse Therapeutics in Up to USD 2.45 Billion Ophthalmolo... Read Post »
Health Tidings Mergers & AcquisitionsHalozyme Licenses Hypercon Technology to Oruka Therapeutics for ORKA-001 Halozyme Licenses Hypercon Technology to Oruka Therapeutics for ORKA-001 Read Post »
Health Tidings Mergers & AcquisitionsArrowhead Takes Aim at MASH Genetics with Madrigal Licensing Deal Arrowhead Takes Aim at MASH Genetics with Madrigal Licensing Deal Read Post »
GenericsLupin Limited Secures FDA Nod for Ravicti Generic Lupin Limited Secures FDA Nod for Ravicti Generic Read Post »
Health Tidings Mergers & AcquisitionsEvotec–Almirall Hit Preclinical Milestone for Skin Disease Therapy Evotec–Almirall Hit Preclinical Milestone for Skin Disease Therapy Read Post »
Health TidingsFDA Grants Rare Pediatric Disease Designation to Atossa’s (Z)-Endoxifen FDA Grants Rare Pediatric Disease Designation to Atossa’s (Z)-Endoxifen 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 »
ManufacturingSerum Institute Starts Development of Meiji’s Japanese Encephalitis Vacci... Serum Institute Starts Development of Meiji’s Japanese Encephalitis Vacci... 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 »
Health TidingsRevolution Medicines Secures FDA Expanded Access for Daraxonrasib in PDAC Revolution Medicines Secures FDA Expanded Access for Daraxonrasib in PDAC 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 »
Health TidingsAstraZeneca Reports Positive FDA Panel Vote for Truqap Combination AstraZeneca Reports Positive FDA Panel Vote for Truqap Combination 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 »
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 »
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 »
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 »
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 »
