Clinical TrialsOtsuka’s Repinatrabit Cuts Blood Phe 67% in Adolescents with PKU Otsuka’s Repinatrabit Cuts Blood Phe 67% in Adolescents with PKU Read Post »
Clinical TrialsUnited’s Tyvaso Delivers Positive Phase 3 Results in IPF United’s Tyvaso Delivers Positive Phase 3 Results in IPF Read Post »
Drugs Safety AlertLilly Warns Compounded Tirzepatide Mixed with B12 May Pose Risks Lilly Warns Compounded Tirzepatide Mixed with B12 May Pose Risks 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 »
New Drug ApprovalFDA Approves Johnson & Johnson’s TECNIS PureSee IOL for Cataract Surg... FDA Approves Johnson & Johnson’s TECNIS PureSee IOL for Cataract Surg... Read Post »
Clinical TrialsCapricor Reports New HOPE-3 Data Showing Deramiocel Improves Cardiac and Fu... Capricor Reports New HOPE-3 Data Showing Deramiocel Improves Cardiac and Fu... Read Post »
Clinical TrialsBridgeBio Unveils Strong Phase 3 Interim Data for BBP-418 in LGMD2I/R9 at M... BridgeBio Unveils Strong Phase 3 Interim Data for BBP-418 in LGMD2I/R9 at M... Read Post »
Clinical TrialsBioMarin Presents New VOXZOGO Data Supporting Early Treatment in Achondropl... BioMarin Presents New VOXZOGO Data Supporting Early Treatment in Achondropl... Read Post »
Clinical TrialsBiogen Initiates Phase 3 Program for Salanersen Following Promising Phase 1... Biogen Initiates Phase 3 Program for Salanersen Following Promising Phase 1... Read Post »
New Drug ApprovalJ&J’s Niraparib–Abiraterone Combo Approved in EU for BRCA-Mutated m... J&J’s Niraparib–Abiraterone Combo Approved in EU for BRCA-Mutated m... Read Post »
New Drug ApprovalEuropean Commission Approves Every-4-Week Dosing of Pegunigalsidase Alfa fo... European Commission Approves Every-4-Week Dosing of Pegunigalsidase Alfa fo... 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 »
Clinical TrialsAscletis’ GLP-1 ASC30 Depot Injection Achieves Promising Phase 2 Results ... Ascletis’ GLP-1 ASC30 Depot Injection Achieves Promising Phase 2 Results ... 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 »
Drugs Safety AlertFDA Issues Warning Letter to Novo Nordisk Over Pharmacovigilance Deficienci... FDA Issues Warning Letter to Novo Nordisk Over Pharmacovigilance Deficienci... Read Post »
Clinical TrialsTelix Reports Positive Safety Results from Phase 3 ProstACT Global Trial of... Telix Reports Positive Safety Results from Phase 3 ProstACT Global Trial of... Read Post »
Clinical TrialsVertex’s Povetacicept Cuts Proteinuria by 52% in Phase 3 RAINIER Interim ... Vertex’s Povetacicept Cuts Proteinuria by 52% in Phase 3 RAINIER Interim ... Read Post »
New Drug ApprovalFDA Approves Wellcovorin (Leucovorin Calcium) as First Treatment for Rare F... FDA Approves Wellcovorin (Leucovorin Calcium) as First Treatment for Rare F... Read Post »
Drugs Safety AlertIpsen Withdraws Tazverik After SYMPHONY-1 Trial Flags Secondary Blood Cance... Ipsen Withdraws Tazverik After SYMPHONY-1 Trial Flags Secondary Blood Cance... 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 »
Clinical TrialsAbbVie Reports Up to 9.8% Weight Loss in Phase 1 MAD Trial of Long-Acting A... AbbVie Reports Up to 9.8% Weight Loss in Phase 1 MAD Trial of Long-Acting A... Read Post »
Clinical TrialsRegeneron, Hansoh Report 19.3% Weight Loss with Dual GLP-1/GIP Drug Olatore... Regeneron, Hansoh Report 19.3% Weight Loss with Dual GLP-1/GIP Drug Olatore... Read Post »
Clinical TrialsPfizer’s Trispecific Antibody Tilrekimig Shows Positive Phase 2 Results i... Pfizer’s Trispecific Antibody Tilrekimig Shows Positive Phase 2 Results i... Read Post »
Clinical TrialsRoche Reports Phase 3 persevERA Setback for Giredestrant in Breast Cancer Roche Reports Phase 3 persevERA Setback for Giredestrant in Breast Cancer Read Post »
Clinical TrialsImmunityBio Files Updated ANKTIVA sBLA with FDA for Papillary NMIBC ImmunityBio Files Updated ANKTIVA sBLA with FDA for Papillary NMIBC 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 »
New Drug ApprovalFDA Approves PYLARIFY TruVu for PSMA PET Imaging in Prostate Cancer FDA Approves PYLARIFY TruVu for PSMA PET Imaging in Prostate Cancer 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 »
New Drug ApprovalEuropean Commission Approves Incyte’s Zynyz Combination Therapy for First... European Commission Approves Incyte’s Zynyz Combination Therapy for First... 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 »
Food WellnessWhy You Should Always Wash Grapes Before Eating: The Hidden Risks Why You Should Always Wash Grapes Before Eating: The Hidden Risks 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 »
Clinical TrialsJOURNAVX Demonstrates High Opioid-Free Recovery Rate in Phase 4 Study JOURNAVX Demonstrates High Opioid-Free Recovery Rate in Phase 4 Study 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 »
Clinical TrialsHelus Pharma Reports Positive Phase 2 Results for HLP004 in GAD Helus Pharma Reports Positive Phase 2 Results for HLP004 in GAD Read Post »
New Drug ApprovalFDA Approves Bristol Myers Squibb’s Sotyktu as First TYK2 Inhibitor for A... FDA Approves Bristol Myers Squibb’s Sotyktu as First TYK2 Inhibitor for A... Read Post »
Clinical TrialsRoche’s Gazyva Shows Strong Phase III Success in Systemic Lupus: ALLEGORY... Roche’s Gazyva Shows Strong Phase III Success in Systemic Lupus: ALLEGORY... Read Post »
Clinical TrialsRoche’s Amylin Analog Petrelintide Delivers Up to 10.7% Weight Loss in Ph... Roche’s Amylin Analog Petrelintide Delivers Up to 10.7% Weight Loss in Ph... Read Post »
Clinical TrialsFDA Places Partial Clinical Hold on PepGen’s FREEDOM2-DM1 Trial of PGN-ED... FDA Places Partial Clinical Hold on PepGen’s FREEDOM2-DM1 Trial of PGN-ED... Read Post »
