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 »
ResearchSemaglutide Recommended by NICE as Add-On Option to Reduce Risk of Heart At... Semaglutide Recommended by NICE as Add-On Option to Reduce Risk of Heart At... Read Post »
New Drug ApprovalRegeneron Pharmaceuticals Secures FDA Nod for Extended EYLEA HD Dosing Up t... Regeneron Pharmaceuticals Secures FDA Nod for Extended EYLEA HD Dosing Up t... Read Post »
New Drug ApprovalFDA Converts Tecartus Approval to Full Approval in Mantle Cell Lymphoma Fol... FDA Converts Tecartus Approval to Full Approval in Mantle Cell Lymphoma Fol... Read Post »
Health TidingsTrump Administration Targets Patented Drug Imports with Conditional Tariffs... Trump Administration Targets Patented Drug Imports with Conditional Tariffs... Read Post »
Mergers & AcquisitionsLupin Completes VISUfarma Acquisition, Expands European Ophthalmology Portf... Lupin Completes VISUfarma Acquisition, Expands European Ophthalmology Portf... Read Post »
Clinical TrialsBridgeBio Reports 54-Month Data, Sustained Survival Benefit with Acoramidis... BridgeBio Reports 54-Month Data, Sustained Survival Benefit with Acoramidis... Read Post »
Health TidingsUltragenyx UX111 Nears Decision After FDA Acceptance Ultragenyx UX111 Nears Decision After FDA Acceptance Read Post »
Clinical TrialsImfinzi – Imjudo Regimen Moves Earlier in HCC with EMERALD-3 Data Imfinzi – Imjudo Regimen Moves Earlier in HCC with EMERALD-3 Data Read Post »
Clinical TrialsInnovent, Ollin Report 20-Week JADE Data Showing OLN324 Durability Edge Ove... Innovent, Ollin Report 20-Week JADE Data Showing OLN324 Durability Edge Ove... Read Post »
Clinical TrialsNovo Nordisk’s Indirect Comparison Data from ORION Puts Wegovy Pill and F... Novo Nordisk’s Indirect Comparison Data from ORION Puts Wegovy Pill and F... Read Post »
Health Tidings Mergers & AcquisitionsZai Lab, Amgen Partner to Advance DLL3 Dual-Targeting Strategy in SCLC Zai Lab, Amgen Partner to Advance DLL3 Dual-Targeting Strategy in SCLC Read Post »
Clinical TrialsInnovent’s Mazdutide 9 mg Shows Up to 18.6% Weight Loss in Phase 2 Obesit... Innovent’s Mazdutide 9 mg Shows Up to 18.6% Weight Loss in Phase 2 Obesit... Read Post »
Health TidingsRay Therapeutics Secures RMAT for RTx-015 in RP Ray Therapeutics Secures RMAT for RTx-015 in RP Read Post »
Health TidingsCogent Files NDA for Bezuclastinib in Second-Line GIST, Backed by Phase 3 P... Cogent Files NDA for Bezuclastinib in Second-Line GIST, Backed by Phase 3 P... Read Post »
Health TidingsFDA Expands Vertex’s ALYFTREK and TRIKAFTA Labels to Cover 95% of CF Pati... FDA Expands Vertex’s ALYFTREK and TRIKAFTA Labels to Cover 95% of CF Pati... Read Post »
Clinical TrialsPepGen Highlights Promising Safety and Splicing Trends in Phase 2 DM1 Study PepGen Highlights Promising Safety and Splicing Trends in Phase 2 DM1 Study Read Post »
New Drug ApprovalLilly Brings Weight-Loss Pill to Market with Foundayo FDA Approval Lilly Brings Weight-Loss Pill to Market with Foundayo FDA Approval Read Post »
Health TidingsAgios Plans sNDA Submission for Mitapivat in Sickle Cell Disease Agios Plans sNDA Submission for Mitapivat in Sickle Cell Disease Read Post »
Clinical TrialsOcugen Completes GARDian3 Dosing for OCU410ST in Stargardt Disease Ocugen Completes GARDian3 Dosing for OCU410ST in Stargardt Disease Read Post »
Mergers & AcquisitionsBioVersys Strikes Ansamycin Antibiotic Deal with Hackensack Meridian Health BioVersys Strikes Ansamycin Antibiotic Deal with Hackensack Meridian Health Read Post »
Mergers & AcquisitionsAxsome-Takeda Deal Brings Balipodect into Late-Stage CNS Development Axsome-Takeda Deal Brings Balipodect into Late-Stage CNS Development Read Post »
