Health TidingsBIZENGRI Receives FDA Priority Voucher in NRG1+ Cholangiocarcinoma BIZENGRI Receives FDA Priority Voucher in NRG1+ Cholangiocarcinoma Read Post »
Clinical TrialsEntrada Strengthens Its Duchenne Pipeline With Positive ENTR-601-44 Study R... Entrada Strengthens Its Duchenne Pipeline With Positive ENTR-601-44 Study R... 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 »
Clinical TrialsIncyte Shows Durable 24-Week Response With Opzelura in Moderate AD Incyte Shows Durable 24-Week Response With Opzelura in Moderate AD 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 »
Clinical TrialsMirum Plans NDA Submission After Positive Volixibat PSC Results Mirum Plans NDA Submission After Positive Volixibat PSC Results Read Post »
ResearchNeurocrine Builds a New Roadmap for Physiologic Steroid Dosing in CAH Neurocrine Builds a New Roadmap for Physiologic Steroid Dosing in CAH Read Post »
ResearchNeurocrine Exposes the Silent Workplace Impact of Tardive Dyskinesia Neurocrine Exposes the Silent Workplace Impact of Tardive Dyskinesia 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 »
Clinical TrialsJohnson & Johnson Breaks a Two-Decade Silence in Perianal Crohn’s Dis... Johnson & Johnson Breaks a Two-Decade Silence in Perianal Crohn’s Dis... Read Post »
New Drug ApprovalBridgeBio Gains ANVISA Clearance in Brazil for BEYONTTRA in ATTR-CM BridgeBio Gains ANVISA Clearance in Brazil for BEYONTTRA in ATTR-CM Read Post »
Clinical TrialsAbbVie Sharpens Its IBD Edge With Real-World SKYRIZI and RINVOQ Results AbbVie Sharpens Its IBD Edge With Real-World SKYRIZI and RINVOQ Results Read Post »
Clinical TrialsCytokinetics Shifts the Hypertrophic Landscape: Aficamten Scores in ACACIA ... Cytokinetics Shifts the Hypertrophic Landscape: Aficamten Scores in ACACIA ... Read Post »
Clinical TrialsViridian Therapeutics Tightens Grip on TED Pipeline With REVEAL-2 Milestone Viridian Therapeutics Tightens Grip on TED Pipeline With REVEAL-2 Milestone Read Post »
Clinical TrialsOncolytics Biotech Reports Strong Early Data for Pelareorep in mCRC Oncolytics Biotech Reports Strong Early Data for Pelareorep in mCRC 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 »
Clinical TrialsLilly Drives Long-Term Stability in UC with Omvoh LUCENT-3 Findings Lilly Drives Long-Term Stability in UC with Omvoh LUCENT-3 Findings Read Post »
Clinical TrialsJohnson & Johnson Doubles Down on IBD Inflammation with Dual-Target The... Johnson & Johnson Doubles Down on IBD Inflammation with Dual-Target The... Read Post »
Clinical TrialsRegeneron and Sanofi Confirm Dupixent Benefits in Eosinophilic Esophagitis Regeneron and Sanofi Confirm Dupixent Benefits in Eosinophilic Esophagitis Read Post »
GenericsLupin Limited Secures FDA Nod for Ravicti Generic Lupin Limited Secures FDA Nod for Ravicti Generic Read Post »
New Drug ApprovalASCENIV Approved for Expanded Pediatric Use in Primary Immunodeficiency ASCENIV Approved for Expanded Pediatric Use in Primary Immunodeficiency 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 »
Clinical TrialsNetwork Analysis Shows CAPLYTA Favored in Adjunctive MDD Treatment Network Analysis Shows CAPLYTA Favored in Adjunctive MDD Treatment 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 »
Clinical TrialsTakeda’s TAK-881 delivers comparable results to HYQVIA in PID Takeda’s TAK-881 delivers comparable results to HYQVIA in PID Read Post »
Clinical TrialsNanoViricides, Inc. Secures FDA Orphan Designation for NV-387 Measles Thera... NanoViricides, Inc. Secures FDA Orphan Designation for NV-387 Measles Thera... 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 »
Clinical TrialsBioMarin Highlights VOXZOGO’s Long-Term Benefits on Bone and Growth BioMarin Highlights VOXZOGO’s Long-Term Benefits on Bone and Growth Read Post »
Mergers & AcquisitionsUCB Acquires Candid Therapeutics in $2.2 Billion Autoimmune Deal UCB Acquires Candid Therapeutics in $2.2 Billion Autoimmune Deal Read Post »
ManufacturingSerum Institute Starts Development of Meiji’s Japanese Encephalitis Vacci... Serum Institute Starts Development of Meiji’s Japanese Encephalitis Vacci... Read Post »
Clinical TrialsAlector Discontinues PROGRESS-AD Trial of Nivisnebart After Futility Analys... Alector Discontinues PROGRESS-AD Trial of Nivisnebart After Futility Analys... 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 »
New Drug ApprovalFDA Clears VEPPANU, First PROTAC Therapy, for Advanced Breast Cancer FDA Clears VEPPANU, First PROTAC Therapy, for Advanced Breast Cancer 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 »
New Drug ApprovalMHRA Clears Linerixibat (Lynavoy) for PBC-Related Itch in Adults MHRA Clears Linerixibat (Lynavoy) for PBC-Related Itch in Adults Read Post »
New Drug ApprovalJohnson & Johnson Secures FDA Nod for STELARA in Pediatric Crohn’s Johnson & Johnson Secures FDA Nod for STELARA in Pediatric Crohn’s Read Post »
Drugs Safety AlertMHRA Sets 5-Day Limit on OTC Nasal Decongestant Sprays MHRA Sets 5-Day Limit on OTC Nasal Decongestant Sprays Read Post »
New Drug ApprovalRhythm Wins EU Approval for IMCIVREE in Acquired Hypothalamic Obesity Rhythm Wins EU Approval for IMCIVREE in Acquired Hypothalamic Obesity Read Post »
New Drug ApprovalArrowhead Breaks the Triglyceride Barrier with REDEMPLO Approval in Austral... Arrowhead Breaks the Triglyceride Barrier with REDEMPLO Approval in Austral... Read Post »
Clinical TrialsCorcept Drives Survival Gain in ALS Despite Missing Primary Endpoint Corcept Drives Survival Gain in ALS Despite Missing Primary Endpoint 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 »
Regulatory & Health PolicyFDA Acts to Restrict Compounding of Popular GLP-1 Therapies from Bulk Subst... FDA Acts to Restrict Compounding of Popular GLP-1 Therapies from Bulk Subst... Read Post »
