Drugs Safety AlertFDA Adds New Safety Warning to ALTUVIIIO Label FDA Adds New Safety Warning to ALTUVIIIO Label Read Post »
Regulatory & Health PolicyFDA Lays the Groundwork for Better Pregnancy Drug Safety Evidence FDA Lays the Groundwork for Better Pregnancy Drug Safety Evidence Read Post »
New Drug ApprovalFDA Approves Bizengri for Rare NRG1-Positive Cholangiocarcinoma FDA Approves Bizengri for Rare NRG1-Positive Cholangiocarcinoma Read Post »
New Drug ApprovalFDA Approves VYVGART for All Adult gMG Antibody Subtypes FDA Approves VYVGART for All Adult gMG Antibody Subtypes Read Post »
New Drug ApprovalGenentech Wins FDA Approval for Ocrevus in Pediatric Multiple Sclerosis Genentech Wins FDA Approval for Ocrevus in Pediatric Multiple Sclerosis Read Post »
Health TidingsServier and Day One Complete Enrollment in Phase 3 OJEMDA Glioma Trial Servier and Day One Complete Enrollment in Phase 3 OJEMDA Glioma Trial Read Post »
Health TidingsCapricor Files Lawsuit Against NS Pharma Over Deramiocel Access Capricor Files Lawsuit Against NS Pharma Over Deramiocel Access Read Post »
Clinical TrialsAtsena Presents Encouraging Long-Term Data in XLRS and LCA1 Atsena Presents Encouraging Long-Term Data in XLRS and LCA1 Read Post »
New Drug ApprovalEU Clears BMS’s Sotyktu for Adults With Psoriatic Arthritis EU Clears BMS’s Sotyktu for Adults With Psoriatic Arthritis Read Post »
New Drug ApprovalInnovent Wins NMPA Approval for Multi-Dose Mazdutide Pen in Type 2 Diabetes Innovent Wins NMPA Approval for Multi-Dose Mazdutide Pen in Type 2 Diabetes Read Post »
New Drug ApprovalNICE Recommends Givinostat for Ambulant DMD Patients Aged 6+ via NHS Innova... NICE Recommends Givinostat for Ambulant DMD Patients Aged 6+ via NHS Innova... Read Post »
Health TidingsEisai and Biogen Face Three-Month FDA Delay for LEQEMBI sBLA Eisai and Biogen Face Three-Month FDA Delay for LEQEMBI sBLA Read Post »
New Drug ApprovalMHRA Authorizes Dawnzera for Patients With Hereditary Angioedema MHRA Authorizes Dawnzera for Patients With Hereditary Angioedema Read Post »
Mergers & AcquisitionsRoche to Acquire PathAI in Up to $1.05 Billion Digital Pathology Deal Roche to Acquire PathAI in Up to $1.05 Billion Digital Pathology Deal Read Post »
Health TidingsAtara and Pierre Fabre Aligns with FDA on Tab-cel BLA Resubmission Path Atara and Pierre Fabre Aligns with FDA on Tab-cel BLA Resubmission Path Read Post »
Health TidingsBayer Wins China Priority Review for Asundexian in Stroke Prevention Bayer Wins China Priority Review for Asundexian in Stroke Prevention Read Post »
ResearchJohnson & Johnson Pushes for Full Depression Recovery Through Generatio... Johnson & Johnson Pushes for Full Depression Recovery Through Generatio... Read Post »
Clinical TrialsFDA Clears NRX-101 Study in Treatment-Resistant Depression and Suicidality FDA Clears NRX-101 Study in Treatment-Resistant Depression and Suicidality Read Post »
Health TidingsAvalo Reports Positive Phase 2 Results for Abdakibart in HS Avalo Reports Positive Phase 2 Results for Abdakibart in HS Read Post »
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 »
