New Drug ApprovalFDA Approves GSK’s Lynavoy as First Treatment for PBC-Related Itch FDA Approves GSK’s Lynavoy as First Treatment for PBC-Related Itch Read Post »
Clinical TrialsPfizer’s TALZENNA Combo Hits rPFS Goal in TALAPRO-3 Pfizer’s TALZENNA Combo Hits rPFS Goal in TALAPRO-3 Read Post »
Drugs Safety AlertEisai Pulls Tazverik in Japan After Global Safety Review Eisai Pulls Tazverik in Japan After Global Safety Review Read Post »
Health TidingsPriavoid Reports Low ARIA Rates for Oral Alzheimer’s Drug PRI-002 Priavoid Reports Low ARIA Rates for Oral Alzheimer’s Drug PRI-002 Read Post »
Clinical TrialsSobi Explores Gamifant for Interferon-Gamma–Driven Sepsis in New Phase 2a... Sobi Explores Gamifant for Interferon-Gamma–Driven Sepsis in New Phase 2a... Read Post »
Health TidingsCSL Works to Restore Hemgenix Supply Amid Temporary Global Stockout CSL Works to Restore Hemgenix Supply Amid Temporary Global Stockout Read Post »
ResearchGrifols Detects Parkinson’s Disease Changes Years Before Diagnosis Grifols Detects Parkinson’s Disease Changes Years Before Diagnosis Read Post »
Health TidingsSanofi Receives U.S. FDA Breakthrough Therapy Designation for Venglustat fo... Sanofi Receives U.S. FDA Breakthrough Therapy Designation for Venglustat fo... Read Post »
New Drug ApprovalJ&J’s Oral IL-23 Therapy ICOTYDE Wins FDA Approval for Plaque Psorias... J&J’s Oral IL-23 Therapy ICOTYDE Wins FDA Approval for Plaque Psorias... Read Post »
GenericsZydus Expands Semaglutide Reach in India Through Co-Marketing Deals with To... Zydus Expands Semaglutide Reach in India Through Co-Marketing Deals with To... Read Post »
Clinical TrialsRhythm’s EMANATE Misses Endpoint, Highlights Subgroup Benefit Rhythm’s EMANATE Misses Endpoint, Highlights Subgroup Benefit Read Post »
Mergers & AcquisitionsSandoz Bets on $320B Biosimilar Opportunity with New Samsung Bioepis Partne... Sandoz Bets on $320B Biosimilar Opportunity with New Samsung Bioepis Partne... Read Post »
Health TidingsIllumina, Veritas Team Up to Integrate Preventive Genomics in Healthcare Illumina, Veritas Team Up to Integrate Preventive Genomics in Healthcare Read Post »
Health TidingsChina Speeds Review of Gyre’s Hydronidone China Speeds Review of Gyre’s Hydronidone Read Post »
Health TidingsSarepta Initiates New ENDEAVOR Cohort to Reduce ELEVIDYS Liver Toxicity Ris... Sarepta Initiates New ENDEAVOR Cohort to Reduce ELEVIDYS Liver Toxicity Ris... Read Post »
Clinical TrialsPfizer’s Next-Gen CDK4 Inhibitor Shows Phase 2 Breast Cancer Benefit Pfizer’s Next-Gen CDK4 Inhibitor Shows Phase 2 Breast Cancer Benefit Read Post »
Clinical TrialsFDA Finds No Bioequivalence Deficiencies in NRx Preservative-Free Ketamine ... FDA Finds No Bioequivalence Deficiencies in NRx Preservative-Free Ketamine ... Read Post »
Health TidingsAldeyra Receives FDA Complete Response Letter for Reproxalap, Citing Lack o... Aldeyra Receives FDA Complete Response Letter for Reproxalap, Citing Lack o... Read Post »
Drugs Safety AlertSCFE Cases Prompt BioMarin to Halt Select VOXZOGO Trials in Rare Growth Dis... SCFE Cases Prompt BioMarin to Halt Select VOXZOGO Trials in Rare Growth Dis... Read Post »
Health Tidings Policy & AcquisitionsZydus’ Sentynl Licenses Progerinin from PRG S&T to Advance Rare Disea... Zydus’ Sentynl Licenses Progerinin from PRG S&T to Advance Rare Disea... Read Post »
Health TidingsSun Pharma’s ILUMYA sBLA Accepted by FDA for Psoriatic Arthritis Sun Pharma’s ILUMYA sBLA Accepted by FDA for Psoriatic Arthritis Read Post »
Clinical TrialsStructure Therapeutics’ Aleniglipron Demonstrates Strong Weight Loss Structure Therapeutics’ Aleniglipron Demonstrates Strong Weight Loss Read Post »
Health TidingsLilly Expands Affordable Access to Zepbound KwikPen for Weight Management Lilly Expands Affordable Access to Zepbound KwikPen for Weight Management Read Post »
Clinical TrialsLilly Advances EBGLYSS Pediatric Indication After Positive ADorable-1 Trial... Lilly Advances EBGLYSS Pediatric Indication After Positive ADorable-1 Trial... Read Post »
Clinical TrialsCytomX Eyes Registrational Path for Varseta-M After Encouraging CRC Data CytomX Eyes Registrational Path for Varseta-M After Encouraging CRC Data Read Post »
Clinical TrialsBayer Reports Positive Phase III FIND-CKD Results for Finerenone Bayer Reports Positive Phase III FIND-CKD Results for Finerenone Read Post »
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 »