Mergers & AcquisitionsFrom Images to Insights: Imagene AI Partners Daiichi Sankyo From Images to Insights: Imagene AI Partners Daiichi Sankyo Read Post »
Mergers & AcquisitionsRoche, C4 Therapeutics Launch “Two-in-One” Targeted Cancer Strategy Roche, C4 Therapeutics Launch “Two-in-One” Targeted Cancer Strategy Read Post »
Clinical TrialsFDA Permits Direct Shift of Ryoncil from IND Stage to Registrational Study FDA Permits Direct Shift of Ryoncil from IND Stage to Registrational Study Read Post »
Health TidingsReplimune Hit With FDA CRL for RP1–Nivolumab in Advanced Melanoma Replimune Hit With FDA CRL for RP1–Nivolumab in Advanced Melanoma Read Post »
Health TidingsFibroBiologics Thymic Organoid (“Artificial Thymus”) Restores Immune Fu... FibroBiologics Thymic Organoid (“Artificial Thymus”) Restores Immune Fu... Read Post »
Health TidingsMacroGenics Regains Momentum as FDA Lifts Hold on LINNET Trial MacroGenics Regains Momentum as FDA Lifts Hold on LINNET Trial Read Post »
Clinical TrialsMilestone Opens Real-World Chapter for CARDAMYST With RESET-PSVT Milestone Opens Real-World Chapter for CARDAMYST With RESET-PSVT Read Post »
Clinical TrialsPREVAIL and KOMET Readouts Set Stage for Alexion at AAN 2026 PREVAIL and KOMET Readouts Set Stage for Alexion at AAN 2026 Read Post »
ManufacturingGSK Ends Wellcovorin Era as FDA Withdraws Leucovorin NDA After Discontinuat... GSK Ends Wellcovorin Era as FDA Withdraws Leucovorin NDA After Discontinuat... Read Post »
ResearchHow Novartis Is Expanding Community Health Programs Globally? How Novartis Is Expanding Community Health Programs Globally? Read Post »
Health TidingsVanda Challenges FDA Legislative Proposal on NDA Timelines and Appeals Vanda Challenges FDA Legislative Proposal on NDA Timelines and Appeals Read Post »
Clinical TrialsVanda Launches Study of NEREUS™ to Reduce Vomiting With GLP-1 Treatments Vanda Launches Study of NEREUS™ to Reduce Vomiting With GLP-1 Treatments Read Post »
Clinical TrialsNew Data Highlight Regenerative Injectables in Menopause, Weight Loss New Data Highlight Regenerative Injectables in Menopause, Weight Loss Read Post »
Mergers & AcquisitionsCosette Pharmaceuticals Acquires SYMPAZAN Portfolio from Assertio Holdings Cosette Pharmaceuticals Acquires SYMPAZAN Portfolio from Assertio Holdings Read Post »
GenericsZenyaku Kogyo to Take Sole Control of Rituxan Sales in Japan After Chugai E... Zenyaku Kogyo to Take Sole Control of Rituxan Sales in Japan After Chugai E... Read Post »
Clinical Trials Mergers & AcquisitionsBoehringer–BioNTech Partner on ES-SCLC Immunotherapy Trial Boehringer–BioNTech Partner on ES-SCLC Immunotherapy Trial Read Post »
Health TidingsEMA Update Enables Non-Cold-Chain Final Delivery for Wegovy in Europe EMA Update Enables Non-Cold-Chain Final Delivery for Wegovy in Europe Read Post »
Health TidingsLilly Expands Obesity Portfolio With Foundayo Market Launch Lilly Expands Obesity Portfolio With Foundayo Market Launch Read Post »
Generics Women & Child HealthGlenmark Expands U.S. Women’s Health Portfolio with FDA Approval of Gener... Glenmark Expands U.S. Women’s Health Portfolio with FDA Approval of Gener... Read Post »
Mergers & AcquisitionsAstellas Taps Dyno’s AI-Designed AAV Capsid to Tackle Muscle Gene Therapy... Astellas Taps Dyno’s AI-Designed AAV Capsid to Tackle Muscle Gene Therapy... Read Post »
CROFortrea Leans into AI and Automation With New FIT Clinical Technology Suite Fortrea Leans into AI and Automation With New FIT Clinical Technology Suite Read Post »
New Drug ApprovalChina Approves GSK’s Exdensur for Chronic Rhinosinusitis with Nasal Polyp... China Approves GSK’s Exdensur for Chronic Rhinosinusitis with Nasal Polyp... Read Post »
Mergers & AcquisitionsShionogi Secures Up to $482 Million BARDA Project BioShield Contract for Fe... Shionogi Secures Up to $482 Million BARDA Project BioShield Contract for Fe... Read Post »
Clinical TrialsPlus Therapeutics Wins FDA Orphan Tag for REYOBIQ Plus Therapeutics Wins FDA Orphan Tag for REYOBIQ Read Post »
Health TidingsBioengineered Liver Therapy miroliverELAP Receives FDA RMAT Designation Bioengineered Liver Therapy miroliverELAP Receives FDA RMAT Designation Read Post »
Clinical TrialsShionogi Presents Real-World CIRCE Data for Cefiderocol Shionogi Presents Real-World CIRCE Data for Cefiderocol Read Post »
Health TidingsFDA Fast Track Designation Granted to SIM0505 for Resistant Ovarian Cancer FDA Fast Track Designation Granted to SIM0505 for Resistant Ovarian Cancer Read Post »
GenericsBiocon and Zydus Receive U.S. FDA Approval for Generic Dapagliflozin Tablet... Biocon and Zydus Receive U.S. FDA Approval for Generic Dapagliflozin Tablet... Read Post »
Health TidingsOutlook Therapeutics Challenges CRL with FDA Dispute Request for LYTENAVA Outlook Therapeutics Challenges CRL with FDA Dispute Request for LYTENAVA Read Post »
GenericsBiocon Rolls Out Bosaya, Aukelso Denosumab Biosimilars Across U.S. Biocon Rolls Out Bosaya, Aukelso Denosumab Biosimilars Across U.S. Read Post »
Clinical TrialsInsmed Halts Brensocatib HS Program After Phase 2b Failure Insmed Halts Brensocatib HS Program After Phase 2b Failure Read Post »
Health Tidings Mergers & AcquisitionsHalozyme and Vertex Sign Global Licensing Deal for Hypercon Drug Delivery T... Halozyme and Vertex Sign Global Licensing Deal for Hypercon Drug Delivery T... Read Post »
Health Tidings Mergers & AcquisitionsBiogen Licenses Alloy AntiClastic ASO Technology Biogen Licenses Alloy AntiClastic ASO Technology Read Post »
Clinical TrialsCatalYm Starts Phase 2b Visugromab Trial in Second-Line HCC CatalYm Starts Phase 2b Visugromab Trial in Second-Line HCC Read Post »
Health Tidings Mergers & AcquisitionsAC Immune Expands Tau Program Under Lilly Agreement AC Immune Expands Tau Program Under Lilly Agreement Read Post »
ManufacturingFDA Issues Warning Letter Over Illegal Online Sale of Unapproved GLP-1 Weig... FDA Issues Warning Letter Over Illegal Online Sale of Unapproved GLP-1 Weig... Read Post »
Health TidingsNuvalent Submits FDA NDA for Neladalkib in Pretreated ALK-Positive NSCLC Nuvalent Submits FDA NDA for Neladalkib in Pretreated ALK-Positive NSCLC Read Post »
Mergers & AcquisitionsGilead Bolsters ADC Strategy with Tubulis Acquisition Worth Up to $5B Gilead Bolsters ADC Strategy with Tubulis Acquisition Worth Up to $5B Read Post »
Health TidingsSavara Secures UK Accelerated Review for MOLBREEVI in Autoimmune PAP Savara Secures UK Accelerated Review for MOLBREEVI in Autoimmune PAP Read Post »
Clinical TrialsNervGen Aligns with FDA on Phase 3 RESTORE Trial of NVG-291 in Chronic Tetr... NervGen Aligns with FDA on Phase 3 RESTORE Trial of NVG-291 in Chronic Tetr... Read Post »
Clinical TrialsSanofi’s Lunsekimig Delivers in Asthma and CRSwNP, Misses Dermatitis Endp... Sanofi’s Lunsekimig Delivers in Asthma and CRSwNP, Misses Dermatitis Endp... Read Post »
Clinical TrialsClimb Bio’s Budoprutug Earns Fast Track Status for pMN Climb Bio’s Budoprutug Earns Fast Track Status for pMN Read Post »
Clinical TrialsTelix Highlights Pipeline Progress, Targets Multiple Regulatory Milestones ... Telix Highlights Pipeline Progress, Targets Multiple Regulatory Milestones ... Read Post »
Health TidingsApnimed Secures Up to $150M Financing for Planned AD109 OSA Therapy Launch Apnimed Secures Up to $150M Financing for Planned AD109 OSA Therapy Launch Read Post »
Health TidingsOncolytics to Discuss Pivotal Pelareorep Study in Late-Line Anal Cancer wit... Oncolytics to Discuss Pivotal Pelareorep Study in Late-Line Anal Cancer wit... Read Post »
Health TidingsMedicus Files Optimized Phase 2 Design for Teverelix in AURr Medicus Files Optimized Phase 2 Design for Teverelix in AURr Read Post »
Clinical Trials Disease & DrugsAmgen Reports Positive Phase 3 Data for Subcutaneous TEPEZZA OBI Amgen Reports Positive Phase 3 Data for Subcutaneous TEPEZZA OBI Read Post »
New Drug ApprovalSenju Commercializes Avarept 0.3% for Dry Eye Disease in Japan Senju Commercializes Avarept 0.3% for Dry Eye Disease in Japan Read Post »
Health TidingsImmunityBio Says ANKTIVA TV Ad Never Aired, Removes Podcast ImmunityBio Says ANKTIVA TV Ad Never Aired, Removes Podcast Read Post »
