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 »
Clinical TrialsPraxis Reports 77% Seizure Reduction with Elsunersen in Early-Seizure Onset... Praxis Reports 77% Seizure Reduction with Elsunersen in Early-Seizure Onset... Read Post »
GenericsNRx Preservative-Free Ketamine ANDA Advances After FDA Labeling Feedback NRx Preservative-Free Ketamine ANDA Advances After FDA Labeling Feedback Read Post »
Health Tidings Mergers & AcquisitionsNeurocrine to Acquire Soleno, Strengthening Rare Disease Portfolio with VYK... Neurocrine to Acquire Soleno, Strengthening Rare Disease Portfolio with VYK... Read Post »
Clinical TrialsRisto-cel Demonstrates Consistent Efficacy and Safety in Sickle Cell Diseas... Risto-cel Demonstrates Consistent Efficacy and Safety in Sickle Cell Diseas... Read Post »
ResearchNIH Study Finds Extended-Release Buprenorphine Superior in Pregnancy-Associ... NIH Study Finds Extended-Release Buprenorphine Superior in Pregnancy-Associ... Read Post »
ResearchNIH-Funded Study Cuts New HIV Infections by 70% in Rural Kenya and Uganda U... NIH-Funded Study Cuts New HIV Infections by 70% in Rural Kenya and Uganda U... Read Post »
ResearchNIH Identifies Novel Opioid Candidate with Strong Analgesia and Reduced Add... NIH Identifies Novel Opioid Candidate with Strong Analgesia and Reduced Add... Read Post »
Medical DevicesUK and US Advance Joint Framework for Medical Device Regulation UK and US Advance Joint Framework for Medical Device Regulation Read Post »
New Drug ApprovalMHRA Approves Sevabertinib for HER2+ Lung Cancer MHRA Approves Sevabertinib for HER2+ Lung Cancer Read Post »
Mergers & AcquisitionsDenali Therapeutics Inc. Regains Full Rights to DNL593 After Takeda Pharmac... Denali Therapeutics Inc. Regains Full Rights to DNL593 After Takeda Pharmac... Read Post »
Health TidingsShionogi Takes Full Control of RADICAVA in $2.5B Deal with Tanabe Pharma Shionogi Takes Full Control of RADICAVA in $2.5B Deal with Tanabe Pharma Read Post »
Health TidingsMerck Begins Registrational Phase 2b/3 Study of MK-8748 in NVAMD Merck Begins Registrational Phase 2b/3 Study of MK-8748 in NVAMD Read Post »
Clinical TrialsPriovant Expands Brepocitinib Development Program with Initiation of Phase ... Priovant Expands Brepocitinib Development Program with Initiation of Phase ... Read Post »
New Drug ApprovalEU Approves First PD-1–Based Regimen KEYTRUDA for Platinum-Resistant Ovar... EU Approves First PD-1–Based Regimen KEYTRUDA for Platinum-Resistant Ovar... Read Post »
Health Tidings Mergers & AcquisitionsRegeneron Partners with TriNetX to Leverage 300 Million Patient Records for... Regeneron Partners with TriNetX to Leverage 300 Million Patient Records for... Read Post »
