Health TidingsImmunityBio Reports Manufacturing Breakthrough and Phase I Safety for M-ceN... ImmunityBio Reports Manufacturing Breakthrough and Phase I Safety for M-ceN... Read Post »
Health TidingsTelix Files NDA Resubmission for Pixclara to Detect Recurrent Glioma Telix Files NDA Resubmission for Pixclara to Detect Recurrent Glioma Read Post »
Health TidingsEisai Partners with Pokémon Sleep to Raise Awareness About Healthy Sleep H... Eisai Partners with Pokémon Sleep to Raise Awareness About Healthy Sleep H... Read Post »
Health TidingsJ&J’s Erda-iDRS Shows Strong Responses in FGFR-Altered NMIBC J&J’s Erda-iDRS Shows Strong Responses in FGFR-Altered NMIBC Read Post »
Health TidingsREGENXBIO Reports Positive Phase I/II AFFINITY DUCHENNE Data for RGX-202 Ge... REGENXBIO Reports Positive Phase I/II AFFINITY DUCHENNE Data for RGX-202 Ge... Read Post »
Health TidingsUltragenyx Reports Positive Phase 3 Enh3ance Results for DTX301 Gene Therap... Ultragenyx Reports Positive Phase 3 Enh3ance Results for DTX301 Gene Therap... Read Post »
Drugs Safety Alert Health TidingsFDA Rolls Out AEMS Safety Dashboard, Saving $120M FDA Rolls Out AEMS Safety Dashboard, Saving $120M Read Post »
Health TidingsLonza Expands Manufacturing Partnership with Genetix to Support Rising Dema... Lonza Expands Manufacturing Partnership with Genetix to Support Rising Dema... Read Post »
Health TidingsCapricor’s Deramiocel BLA Review Reinstated by FDA Following HOPE-3 T... Capricor’s Deramiocel BLA Review Reinstated by FDA Following HOPE-3 T... Read Post »
Health TidingsAstellas’ Phase 3 PASHA Study of Xospata Fails to Improve Overall Surviva... Astellas’ Phase 3 PASHA Study of Xospata Fails to Improve Overall Surviva... Read Post »
Health TidingsLundbeck Completes Patient Randomization in Phase 3 MASCOT Trial of Amlenet... Lundbeck Completes Patient Randomization in Phase 3 MASCOT Trial of Amlenet... Read Post »
Health TidingsBMS’ Mezigdomide Triplet Delivers PFS Win in Phase 3 SUCCESSOR-2 Study BMS’ Mezigdomide Triplet Delivers PFS Win in Phase 3 SUCCESSOR-2 Study Read Post »
Health TidingsAstraZeneca and Daiichi Sankyo’s Enhertu sBLA for HER2-Positive Breast Ca... AstraZeneca and Daiichi Sankyo’s Enhertu sBLA for HER2-Positive Breast Ca... Read Post »
Health Tidings Policy & AcquisitionsRapport Therapeutics Partners with Tenacia to Develop RAP-219 for Neurologi... Rapport Therapeutics Partners with Tenacia to Develop RAP-219 for Neurologi... Read Post »
Health Tidings Policy & AcquisitionsNovo Nordisk Resolves GLP-1 Dispute with Hims & Hers, Expands Access to... Novo Nordisk Resolves GLP-1 Dispute with Hims & Hers, Expands Access to... Read Post »
Health TidingsXenon’s Azetukalner Delivers Strong Phase 3 Win in Focal Seizures, Sets S... Xenon’s Azetukalner Delivers Strong Phase 3 Win in Focal Seizures, Sets S... Read Post »
Health Tidings Policy & AcquisitionsGSK Licenses Linerixibat to Alfasigma in Deal Worth Up to $690 Million GSK Licenses Linerixibat to Alfasigma in Deal Worth Up to $690 Million Read Post »
Health TidingsLilly’s Obesity Medicines to Become More Affordable Under Medicare Progra... Lilly’s Obesity Medicines to Become More Affordable Under Medicare Progra... Read Post »
Health TidingsFDA Issues Complete Response Letter for Chiesi’s Idebenone in Rare Vision... FDA Issues Complete Response Letter for Chiesi’s Idebenone in Rare Vision... Read Post »
Health TidingsDr. Vinay Prasad to Step Down as FDA CBER Director After Year of Regulatory... Dr. Vinay Prasad to Step Down as FDA CBER Director After Year of Regulatory... Read Post »
Health TidingsSavara’s MOLBREEVI Clears FDA Day 74 Milestone; No Advisory Committee Pla... Savara’s MOLBREEVI Clears FDA Day 74 Milestone; No Advisory Committee Pla... Read Post »
Health TidingsNemluvio and Relfydess Emerge as Key Drivers in Galderma’s Record 2025 Pe... Nemluvio and Relfydess Emerge as Key Drivers in Galderma’s Record 2025 Pe... Read Post »
Health Tidings Policy & AcquisitionsTenaya Therapeutics and Alnylam Collaborate to Discover Genetic Targets for... Tenaya Therapeutics and Alnylam Collaborate to Discover Genetic Targets for... Read Post »
Health Tidings Policy & AcquisitionsServier Acquires Day One Biopharmaceuticals for $2.5 Billion to Bolster Rar... Servier Acquires Day One Biopharmaceuticals for $2.5 Billion to Bolster Rar... Read Post »
Health TidingsOutlook Therapeutics Charts Regulatory Path Forward for LYTENAVA After FDA ... Outlook Therapeutics Charts Regulatory Path Forward for LYTENAVA After FDA ... Read Post »
Health TidingsCanada Taps CSL Seqirus for Cell-Based Pandemic Flu Vaccines in New Prepare... Canada Taps CSL Seqirus for Cell-Based Pandemic Flu Vaccines in New Prepare... Read Post »
Health TidingsOral Epinephrine on Track: Aquestive Maps Path Forward for Anaphylm Oral Epinephrine on Track: Aquestive Maps Path Forward for Anaphylm Read Post »
Health Tidings Policy & AcquisitionsSanofi Licenses Rovadicitinib from Sino Biopharm in $1.53B Global Deal Sanofi Licenses Rovadicitinib from Sino Biopharm in $1.53B Global Deal Read Post »
Health TidingsBridging Obesity Care Gaps: Lilly’s New Employer Platform Bridging Obesity Care Gaps: Lilly’s New Employer Platform Read Post »
Health Tidings Policy & AcquisitionsDuvakitug Gets $400M Boost: Teva’s IBD Pivot with Blackstone Duvakitug Gets $400M Boost: Teva’s IBD Pivot with Blackstone Read Post »
Health Tidings Policy & AcquisitionsGSK Finalizes $2.2B RAPT Buyout: Ozureprubart Eyes Quarterly Dosing for Foo... GSK Finalizes $2.2B RAPT Buyout: Ozureprubart Eyes Quarterly Dosing for Foo... Read Post »
Health TidingsModerna Settles Global Patent Litigation with Arbutus and Genevant for $950... Moderna Settles Global Patent Litigation with Arbutus and Genevant for $950... Read Post »
Health TidingsFDA Cracks Down on Illegal Marketing of Compounded GLP-1 Drugs, Issues Warn... FDA Cracks Down on Illegal Marketing of Compounded GLP-1 Drugs, Issues Warn... Read Post »
Health TidingsJapan Grants Orphan Drug Status to Sanofi’s Rilzabrutinib for Rare IgG4-R... Japan Grants Orphan Drug Status to Sanofi’s Rilzabrutinib for Rare IgG4-R... Read Post »
Health TidingsFDA Grants Priority Review to Takeda’s Rusfertide for Polycythemia Vera FDA Grants Priority Review to Takeda’s Rusfertide for Polycythemia Vera Read Post »
Health TidingsJohnson & Johnson Advances Nipocalimab in Lupus with Latest FDA Fast Tr... Johnson & Johnson Advances Nipocalimab in Lupus with Latest FDA Fast Tr... Read Post »
Health TidingsOno Leverages Congruence Revenir™ for Neurology, Immunology Breakthroughs Ono Leverages Congruence Revenir™ for Neurology, Immunology Breakthroughs Read Post »
Health TidingsAtara and Pierre Fabre Seek FDA Type A Meeting to Advance Tab-Cel After CRL Atara and Pierre Fabre Seek FDA Type A Meeting to Advance Tab-Cel After CRL Read Post »
Health TidingsFDA Grants Rare Public Hearing on Vanda’s HETLIOZ® Jet Lag Approval ... FDA Grants Rare Public Hearing on Vanda’s HETLIOZ® Jet Lag Approval ... Read Post »
Health TidingsPhase 3 Setback for Aardvark’s ARD-101 as HERO Enrollment Freezes Phase 3 Setback for Aardvark’s ARD-101 as HERO Enrollment Freezes Read Post »
Health TidingsIntellia Gains Complete FDA Greenlight for Nex-z ATTR Trials Post-Hold Reso... Intellia Gains Complete FDA Greenlight for Nex-z ATTR Trials Post-Hold Reso... Read Post »
Health TidingsJohnson & Johnson Unveils Promising Phase 1b Data for Pasritamig Plus D... Johnson & Johnson Unveils Promising Phase 1b Data for Pasritamig Plus D... Read Post »
Health TidingsHuntington’s Hope Dims? FDA Urges Sham-Controlled Trial for uniQure AMT-1... Huntington’s Hope Dims? FDA Urges Sham-Controlled Trial for uniQure AMT-1... Read Post »
Health TidingsRoche Fenebrutinib Phase III Success: 51% Fewer MS Relapses Roche Fenebrutinib Phase III Success: 51% Fewer MS Relapses Read Post »
Health TidingsFDA Accepts BLA for Imsidolimab: A Precision Therapy Poised to Transform Ge... FDA Accepts BLA for Imsidolimab: A Precision Therapy Poised to Transform Ge... Read Post »
Health TidingsOno Pharmaceutical Ends Forxiga Partnership with AstraZeneca in Japan Ono Pharmaceutical Ends Forxiga Partnership with AstraZeneca in Japan Read Post »
Health TidingsFDA Grants Priority Review to Ionis’ Olezarsen for Severe Hypertrigly... FDA Grants Priority Review to Ionis’ Olezarsen for Severe Hypertrigly... Read Post »
Health TidingsEMA CHMP Backs Moderna’s mCOMBRIAX®: Pioneering Flu-COVID Combo Vacc... EMA CHMP Backs Moderna’s mCOMBRIAX®: Pioneering Flu-COVID Combo Vacc... Read Post »
Health Tidings Policy & AcquisitionsNovartis Finalizes $12B Avidity Buyout for AOC Muscle Tech Novartis Finalizes $12B Avidity Buyout for AOC Muscle Tech Read Post »
