GenericsApotex Strikes First in U.S. Semaglutide Generic Push Apotex Strikes First in U.S. Semaglutide Generic Push 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 »
ManufacturingGSK Ends Wellcovorin Era as FDA Withdraws Leucovorin NDA After Discontinuat... GSK Ends Wellcovorin Era as FDA Withdraws Leucovorin NDA After Discontinuat... 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 »
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 »
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 »
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 »
Health TidingsBioengineered Liver Therapy miroliverELAP Receives FDA RMAT Designation Bioengineered Liver Therapy miroliverELAP Receives FDA RMAT Designation 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 »
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 »
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 »
Health TidingsSavara Secures UK Accelerated Review for MOLBREEVI in Autoimmune PAP Savara Secures UK Accelerated Review for MOLBREEVI in Autoimmune PAP 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 »
Health TidingsImmunityBio Says ANKTIVA TV Ad Never Aired, Removes Podcast ImmunityBio Says ANKTIVA TV Ad Never Aired, Removes Podcast 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 »
Medical DevicesUK and US Advance Joint Framework for Medical Device Regulation UK and US Advance Joint Framework for Medical Device Regulation 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 »
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 »
Health TidingsTrump Administration Targets Patented Drug Imports with Conditional Tariffs... Trump Administration Targets Patented Drug Imports with Conditional Tariffs... Read Post »
Health TidingsUltragenyx UX111 Nears Decision After FDA Acceptance Ultragenyx UX111 Nears Decision After FDA Acceptance 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 »
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 »
Health TidingsAgios Plans sNDA Submission for Mitapivat in Sickle Cell Disease Agios Plans sNDA Submission for Mitapivat in Sickle Cell Disease Read Post »
GenericsFrom Approval to Acceptance: Teva Expands Portfolio with PONLIMSI™ and Xo... From Approval to Acceptance: Teva Expands Portfolio with PONLIMSI™ and Xo... Read Post »
Health TidingsScholar Rock Resubmits Apitegromab BLA to FDA Scholar Rock Resubmits Apitegromab BLA to FDA Read Post »
Health Tidings Mergers & AcquisitionsBiogen’s $5.6B Apellis Deal Boosts Immunology and Rare Disease Portfolio Biogen’s $5.6B Apellis Deal Boosts Immunology and Rare Disease Portfolio Read Post »
Health Tidings Mergers & AcquisitionsGalapagos – Gilead Finalize Ouro-Linked Deal to Advance Gamgertamig Galapagos – Gilead Finalize Ouro-Linked Deal to Advance Gamgertamig Read Post »
Health TidingsAquestive Aligns with FDA on Anaphylm NDA Resubmission, Aim Q3 2026 Filing Aquestive Aligns with FDA on Anaphylm NDA Resubmission, Aim Q3 2026 Filing Read Post »
Health TidingsEU Expands Kerendia Label: Bayer’s Finerenone Approved for Broader Heart ... EU Expands Kerendia Label: Bayer’s Finerenone Approved for Broader Heart ... Read Post »
Health Tidings Mergers & AcquisitionsAfter NVIDIA, Lilly Signs New AI Drug Discovery Deal with Insilico After NVIDIA, Lilly Signs New AI Drug Discovery Deal with Insilico Read Post »
Health TidingsFDA Clears IND for Sialic Acid Prodrug UX016 in GNEM FDA Clears IND for Sialic Acid Prodrug UX016 in GNEM Read Post »
Health TidingsAmgen’s Repatha Lowers First CV Risk in High-Risk Patients Amgen’s Repatha Lowers First CV Risk in High-Risk Patients Read Post »
Health TidingsSanofi’s Sarclisa SC Gets CHMP Nod with OBI Option Sanofi’s Sarclisa SC Gets CHMP Nod with OBI Option Read Post »
