Health TidingsAxsome’s AXS-12 NDA for Narcolepsy Cataplexy Accepted by FDA Axsome’s AXS-12 NDA for Narcolepsy Cataplexy Accepted by FDA Read Post »
Health TidingsVeradermics’ Oral VDPHL01 Shows Strong Hair Growth in Phase 2 Study o... Veradermics’ Oral VDPHL01 Shows Strong Hair Growth in Phase 2 Study o... Read Post »
Health TidingsRAG-17 Reduced SOD1 by 69% in Phase 1 Amyotrophic Lateral Sclerosis Trial RAG-17 Reduced SOD1 by 69% in Phase 1 Amyotrophic Lateral Sclerosis Trial Read Post »
Health TidingsOrelabrutinib Significantly Improves Progression-Free Survival as First-Lin... Orelabrutinib Significantly Improves Progression-Free Survival as First-Lin... Read Post »
Health TidingsApnimed’s AD109 NDA Accepted by FDA for Obstructive Sleep Apnea Apnimed’s AD109 NDA Accepted by FDA for Obstructive Sleep Apnea Read Post »
Health TidingsFDA Grants Priority Review to Roche’s Gazyva/Gazyvaro for Adults with Pri... FDA Grants Priority Review to Roche’s Gazyva/Gazyvaro for Adults with Pri... Read Post »
GenericsFDA Approves First Generic Afatinib Tablets for EGFR-Mutated NSCLC FDA Approves First Generic Afatinib Tablets for EGFR-Mutated NSCLC Read Post »
Health Tidings Regulatory & Health PolicyFDA Releases First Psychedelic Drug Development Guidance FDA Releases First Psychedelic Drug Development Guidance Read Post »
Health TidingsSummit Sells Phase III Antibiotic Ridinilazole to Biossil in Up to $105 Mil... Summit Sells Phase III Antibiotic Ridinilazole to Biossil in Up to $105 Mil... Read Post »
Health Tidings Mergers & AcquisitionsNovartis Partners With Chai Discovery to Advance AI Antibody Discovery Novartis Partners With Chai Discovery to Advance AI Antibody Discovery Read Post »
Health Tidings Mergers & AcquisitionsSpero Secures Global Rights to Innovent’s Anti-CD40L Antibody IBI355 in U... Spero Secures Global Rights to Innovent’s Anti-CD40L Antibody IBI355 in U... Read Post »
Health Tidings Mergers & AcquisitionsAstraZeneca Licenses Zegfrovy from Dizal in Up to $1.5 Billion Deal to Expa... AstraZeneca Licenses Zegfrovy from Dizal in Up to $1.5 Billion Deal to Expa... Read Post »
Health Tidings Mergers & AcquisitionsIndonesia Grants Takeda Plasma Fractionation License for PDMP Production Indonesia Grants Takeda Plasma Fractionation License for PDMP Production Read Post »
Health TidingsAgenus Secures $340M to Advance ROBBIN Trial of Botensilimab + Balstilimab ... Agenus Secures $340M to Advance ROBBIN Trial of Botensilimab + Balstilimab ... Read Post »
Health TidingsArmata Receives FDA Agreement on Pediatric Study Plan for AP-SA02 Armata Receives FDA Agreement on Pediatric Study Plan for AP-SA02 Read Post »
Health TidingsBioMarin’s VOXZOGO sNDA Accepted by FDA for Full Approval in Children wit... BioMarin’s VOXZOGO sNDA Accepted by FDA for Full Approval in Children wit... Read Post »
Health TidingsIpsen Reports Positive Phase IIIb Results for IQIRVO in PBC Ipsen Reports Positive Phase IIIb Results for IQIRVO in PBC Read Post »
Health TidingsLongeveron Reports New Phase 2a Data Showing Laromestrocel Reduced Brain In... Longeveron Reports New Phase 2a Data Showing Laromestrocel Reduced Brain In... Read Post »
Health TidingsLatarcibart Reduces Annual Bleeding Rate by 81% in Phase 1/2 Study of Von W... Latarcibart Reduces Annual Bleeding Rate by 81% in Phase 1/2 Study of Von W... Read Post »
Health TidingsLongBio Pharma Wins FDA IND Clearance for LP-003 Peanut Allergy Trial LongBio Pharma Wins FDA IND Clearance for LP-003 Peanut Allergy Trial Read Post »
Health TidingsMezigdomide NDA Accepted After Phase 3 Trial Doubled Progression-Free Survi... Mezigdomide NDA Accepted After Phase 3 Trial Doubled Progression-Free Survi... Read Post »
Health TidingsOxford Launches First Phase I Bundibugyo Ebola Vaccine Trial Oxford Launches First Phase I Bundibugyo Ebola Vaccine Trial Read Post »
ManufacturingMHRA Approves UK Plasma Manufacturing for Five High-Priority Medicines MHRA Approves UK Plasma Manufacturing for Five High-Priority Medicines Read Post »
Health Tidings Mergers & AcquisitionsSino Biopharma Secures China Rights to GSK’s Trelegy and Anoro Sino Biopharma Secures China Rights to GSK’s Trelegy and Anoro Read Post »
Health TidingsFDA Issues Complete Response Letter for Elevar’s Rivoceranib Plus Cam... FDA Issues Complete Response Letter for Elevar’s Rivoceranib Plus Cam... Read Post »
Health TidingsSino Files TQB3454 NDA in China for IDH1-Mutant Biliary Tract Cancer Sino Files TQB3454 NDA in China for IDH1-Mutant Biliary Tract Cancer Read Post »
Health TidingsArialys Therapeutics Receives FDA Fast Track Designation for ART5803 in Ant... Arialys Therapeutics Receives FDA Fast Track Designation for ART5803 in Ant... Read Post »
Health TidingsOrelabrutinib Becomes First BTK Inhibitor to Show Clinical Efficacy in Lupu... Orelabrutinib Becomes First BTK Inhibitor to Show Clinical Efficacy in Lupu... Read Post »
Health Tidings Mergers & AcquisitionsSerum Institute, DNDi Advance VIS513 Into Global Phase III Dengue Trial Serum Institute, DNDi Advance VIS513 Into Global Phase III Dengue Trial Read Post »
Health TidingsSaol Resubmits FDA Application for SL1009 in Rare Pediatric Mitochondrial D... Saol Resubmits FDA Application for SL1009 in Rare Pediatric Mitochondrial D... Read Post »
GenericsFDA Accepts Amneal and Adalvo ANDAs for Generic Tirzepatide Autoinjectors FDA Accepts Amneal and Adalvo ANDAs for Generic Tirzepatide Autoinjectors Read Post »
Health Tidings Mergers & AcquisitionsTeva Secures Global Rights to Polpharma Biologics’ Proposed Biosimilar to... Teva Secures Global Rights to Polpharma Biologics’ Proposed Biosimilar to... Read Post »
Health Tidings Mergers & AcquisitionsBayer Launches Clinical Trials Alliance With CU Anschutz Bayer Launches Clinical Trials Alliance With CU Anschutz Read Post »
GenericsTeva, Samsung Bioepis Partner to Commercialize OPUVIZ Aflibercept Biosimila... Teva, Samsung Bioepis Partner to Commercialize OPUVIZ Aflibercept Biosimila... Read Post »
Health TidingsAllotera Secures $35M to Advance Pivotal Allogeneic CAR‑T Sofi‑cel in T... Allotera Secures $35M to Advance Pivotal Allogeneic CAR‑T Sofi‑cel in T... Read Post »
Health TidingsMerck Secures FDA Breakthrough Therapy Designation for Enpatoran in Lupus P... Merck Secures FDA Breakthrough Therapy Designation for Enpatoran in Lupus P... Read Post »
Health TidingsGrünenthal Receives FDA Orphan Drug and Rare Pediatric Disease Designation... Grünenthal Receives FDA Orphan Drug and Rare Pediatric Disease Designation... Read Post »
Health TidingsArcutis’ ZORYVE Cream sNDA Accepted by FDA for Infants with Atopic Dermat... Arcutis’ ZORYVE Cream sNDA Accepted by FDA for Infants with Atopic Dermat... Read Post »
Health Tidings Mergers & AcquisitionsSino Biopharmaceutical Licenses COPD Candidate TQC3721 to AstraZeneca in Up... Sino Biopharmaceutical Licenses COPD Candidate TQC3721 to AstraZeneca in Up... Read Post »
Health TidingsImmunome’s Varegacestat NDA Accepted by FDA for Desmoid Tumors Immunome’s Varegacestat NDA Accepted by FDA for Desmoid Tumors Read Post »
Health Tidings Mergers & AcquisitionsChemomab, Scipher Merge to Advance Nebokitug in Rheumatoid Arthritis Chemomab, Scipher Merge to Advance Nebokitug in Rheumatoid Arthritis Read Post »
Health TidingsFDA Aligns With OKYO’s NEPTUNE Phase 3 Trial of Urcosimod in Neuropathic ... FDA Aligns With OKYO’s NEPTUNE Phase 3 Trial of Urcosimod in Neuropathic ... Read Post »
Health TidingsVanda’s VCA-894A Receives FDA Rare Pediatric Disease Designation for Ultr... Vanda’s VCA-894A Receives FDA Rare Pediatric Disease Designation for Ultr... Read Post »
Health TidingsAgios’ Mitapivat Gains FDA Priority Review for Sickle Cell Disease Agios’ Mitapivat Gains FDA Priority Review for Sickle Cell Disease Read Post »
Health TidingsAxsome Moves Solriamfetol into Late-Stage Trial for Children with ADHD Axsome Moves Solriamfetol into Late-Stage Trial for Children with ADHD Read Post »
Health Tidings Mergers & AcquisitionsPraxis Partners with Remagine Labs to Develop Transdermal Patch for Ulixaca... Praxis Partners with Remagine Labs to Develop Transdermal Patch for Ulixaca... Read Post »
Health TidingsFDA Confirms Phase 3 Path for Alterity’s ATH434 in Multiple System Atroph... FDA Confirms Phase 3 Path for Alterity’s ATH434 in Multiple System Atroph... Read Post »
Health TidingsMeiraGTx Wins Up to $400 Million Funding for Gene Therapy Pipeline MeiraGTx Wins Up to $400 Million Funding for Gene Therapy Pipeline Read Post »
Health TidingsRevolution Medicines Advances Daraxonrasib Toward Europe After EMA Starts P... Revolution Medicines Advances Daraxonrasib Toward Europe After EMA Starts P... Read Post »
Health TidingsInsilico Medicine Advances AI-Discovered Rentosertib into Phase III Trial f... Insilico Medicine Advances AI-Discovered Rentosertib into Phase III Trial f... Read Post »
