New Drug ApprovalAstraZeneca’s Imfinzi Combo Approved in EU for Gastric Cancer AstraZeneca’s Imfinzi Combo Approved in EU for Gastric Cancer Read Post »
Clinical TrialsFDA Allows U.S. Enrollment in BioVersys Phase 3 Trial of BV100 for Drug-Res... FDA Allows U.S. Enrollment in BioVersys Phase 3 Trial of BV100 for Drug-Res... Read Post »
Clinical TrialsNRx Targets FDA Approval for NRX-100 in Severe Depression NRx Targets FDA Approval for NRX-100 in Severe Depression Read Post »
Health Tidings Policy & AcquisitionsSamsung Bioepis Partners with G2GBIO to Develop Long-Acting Semaglutide Usi... Samsung Bioepis Partners with G2GBIO to Develop Long-Acting Semaglutide Usi... Read Post »
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 »
Clinical TrialsAbbott’s Libre CGM Improves HbA1c and Time-in-Range in FreeDM2 Trial Abbott’s Libre CGM Improves HbA1c and Time-in-Range in FreeDM2 Trial Read Post »
Lifestyle WellnessBiotin for Hair Growth: Science, Deficiency, and Clinical Evidence Biotin for Hair Growth: Science, Deficiency, and Clinical Evidence Read Post »
New Drug ApprovalChina Approves Zydus’ Desidustat for Renal Anaemia in Chronic Kidney Dise... China Approves Zydus’ Desidustat for Renal Anaemia in Chronic Kidney Dise... 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 »
New Drug ApprovalFDA Broadens Use of GSK’s Arexvy to At-Risk Adults 18–49 FDA Broadens Use of GSK’s Arexvy to At-Risk Adults 18–49 Read Post »
New Drug ApprovalCosentyx Becomes First IL-17A Inhibitor Approved for Adolescents in Hidrade... Cosentyx Becomes First IL-17A Inhibitor Approved for Adolescents in Hidrade... Read Post »
Lifestyle WellnessMouth Taping for Better Sleep: Does Sleeping with Tape on Your Mouth Actual... Mouth Taping for Better Sleep: Does Sleeping with Tape on Your Mouth Actual... Read Post »
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 »
