Health TidingsCHMP Backs Opzelura Cream for Moderate Atopic Dermatitis in Adults Across E... CHMP Backs Opzelura Cream for Moderate Atopic Dermatitis in Adults Across E... Read Post »
Health TidingsEMA Panel Recommends Revoking EU Approval of TAVNEOS; CSL Reaffirms Commitm... EMA Panel Recommends Revoking EU Approval of TAVNEOS; CSL Reaffirms Commitm... Read Post »
Health TidingsXspray Advances FDA Reviews of Nilopki and Dasynoc as Key Regulatory Milest... Xspray Advances FDA Reviews of Nilopki and Dasynoc as Key Regulatory Milest... Read Post »
GenericsLupin Receives U.S. FDA Tentative Approval for Generic Enzalutamide Tablets Lupin Receives U.S. FDA Tentative Approval for Generic Enzalutamide Tablets Read Post »
Health Tidings Mergers & AcquisitionsMerck KGaA to Acquire Bio-Techne for $11.3 Billion to Expand Life Science P... Merck KGaA to Acquire Bio-Techne for $11.3 Billion to Expand Life Science P... Read Post »
Health TidingsRecce Raises A$4 Million to Advance R327 Trial in DFI Recce Raises A$4 Million to Advance R327 Trial in DFI Read Post »
Health TidingsMHRA Validates Eisai’s Taletrectinib for ROS1-Positive Lung Cancer MHRA Validates Eisai’s Taletrectinib for ROS1-Positive Lung Cancer Read Post »
Health Tidings Mergers & AcquisitionsNovartis Partners With Antares in Up to $1.9 Billion Oncology Drug Deal Novartis Partners With Antares in Up to $1.9 Billion Oncology Drug Deal Read Post »
Health TidingsMHRA Approves Pediatric Investigation Plan for Ebstrocel in RDEB MHRA Approves Pediatric Investigation Plan for Ebstrocel in RDEB Read Post »
Health Tidings Mergers & AcquisitionsIonis Partners with Recordati to Commercialize Zilganersen for Alexander Di... Ionis Partners with Recordati to Commercialize Zilganersen for Alexander Di... Read Post »
Health TidingsOllin Raises $330 Million to Advance Phase 3 Trials of VEGF/Ang2 Bispecific... Ollin Raises $330 Million to Advance Phase 3 Trials of VEGF/Ang2 Bispecific... Read Post »
Health Tidings Mergers & AcquisitionsEli Lilly Expands Abbisko Alliance in Up to $1.9 Billion Multi-Target Drug ... Eli Lilly Expands Abbisko Alliance in Up to $1.9 Billion Multi-Target Drug ... Read Post »
Health TidingsFDA Converts Tecelra to Full Approval, Broadens Label to Adolescents FDA Converts Tecelra to Full Approval, Broadens Label to Adolescents Read Post »
Health TidingsADC Therapeutics Cuts Workforce by 17% to Support ZYNLONTA Regulatory Expan... ADC Therapeutics Cuts Workforce by 17% to Support ZYNLONTA Regulatory Expan... Read Post »
Health TidingsFDA Clears Phase 3 Path for Entera’s Oral Osteoporosis Therapy EB613 FDA Clears Phase 3 Path for Entera’s Oral Osteoporosis Therapy EB613 Read Post »
Health TidingsNICE Recommends Cemiplimab for Recurrent or Metastatic Cervical Cancer on t... NICE Recommends Cemiplimab for Recurrent or Metastatic Cervical Cancer on t... Read Post »
Health Tidings Mergers & AcquisitionsNuvectis Adds Late-Stage NXP100 and NXP200 in Haisco Licensing Deal Nuvectis Adds Late-Stage NXP100 and NXP200 in Haisco Licensing Deal Read Post »
GenericsFDA Approves First Generic Rifapentine Tablets for Active and Latent Tuberc... FDA Approves First Generic Rifapentine Tablets for Active and Latent Tuberc... Read Post »
Health TidingsFDA Modernizes Clinical Research Through Operation TrialBlazer FDA Modernizes Clinical Research Through Operation TrialBlazer Read Post »
Health TidingsBreakthrough T1D Backs MannKind’s INHALE-1ST Trial of Afrezza in Newly Di... Breakthrough T1D Backs MannKind’s INHALE-1ST Trial of Afrezza in Newly Di... Read Post »
Health TidingsGondolaBio Reports Positive Phase 2a Results for PORT-77 in EPP GondolaBio Reports Positive Phase 2a Results for PORT-77 in EPP Read Post »
Health TidingsFDA Agrees on Phase 3 Plan for Galectin’s Belapectin in MASH Cirrhosi... FDA Agrees on Phase 3 Plan for Galectin’s Belapectin in MASH Cirrhosi... Read Post »
Health TidingsIMUNON Reports Positive Safety Review for Phase 3 IMNN-001 Ovarian Cancer S... IMUNON Reports Positive Safety Review for Phase 3 IMNN-001 Ovarian Cancer S... Read Post »
Health Tidings Mergers & AcquisitionsInsilico and SK Biopharmaceuticals Pursue New Neuroimmune Treatments Using ... Insilico and SK Biopharmaceuticals Pursue New Neuroimmune Treatments Using ... Read Post »
Health TidingsFDA Rejects Cytisinicline NDA for Now, Requests Manufacturing Resolution FDA Rejects Cytisinicline NDA for Now, Requests Manufacturing Resolution Read Post »
Health TidingsFDA Grants Rolling Review for QTORIN Rapamycin NDA in Rare Lymphatic Malfor... FDA Grants Rolling Review for QTORIN Rapamycin NDA in Rare Lymphatic Malfor... Read Post »
Health TidingsFDA Clears EAP for NRX-101 to Enhance TMS in Treatment-Resistant Depression FDA Clears EAP for NRX-101 to Enhance TMS in Treatment-Resistant Depression Read Post »
Health TidingsMedicus Showcases SkinJect and Teverelix Development Progress at BIO Intern... Medicus Showcases SkinJect and Teverelix Development Progress at BIO Intern... Read Post »
Health TidingsFDA Grants Breakthrough Status to Elsunersen After Strong Seizure Reduction... FDA Grants Breakthrough Status to Elsunersen After Strong Seizure Reduction... Read Post »
Health Tidings Mergers & AcquisitionsAbbVie to Acquire Apogee Therapeutics for $10.9B, Expanding Immunology and ... AbbVie to Acquire Apogee Therapeutics for $10.9B, Expanding Immunology and ... Read Post »
Health TidingsRegeneron Secures FDA Priority Review for Cemdisiran in gMG Regeneron Secures FDA Priority Review for Cemdisiran in gMG Read Post »
Health TidingsREGENXBIO Advances NAVSUNLI Toward Accelerated FDA Approval REGENXBIO Advances NAVSUNLI Toward Accelerated FDA Approval Read Post »
Health TidingsFDA Seeks Major Label Updates for Testosterone Therapy Following Review of ... FDA Seeks Major Label Updates for Testosterone Therapy Following Review of ... Read Post »
GenericsFDA Grants Tentative Approval to Alembic’s Generic Binimetinib FDA Grants Tentative Approval to Alembic’s Generic Binimetinib Read Post »
Health TidingsKither’s KIT2014 Advances as a Potential Dual-Action Therapy for Mult... Kither’s KIT2014 Advances as a Potential Dual-Action Therapy for Mult... Read Post »
Health TidingsChugai Files New Drug Application in Japan for Sparsentan in IgA Nephropath... Chugai Files New Drug Application in Japan for Sparsentan in IgA Nephropath... Read Post »
Health TidingsSanofi Wins Japan Approval for Subcutaneous Sarclisa in Multiple Myeloma Sanofi Wins Japan Approval for Subcutaneous Sarclisa in Multiple Myeloma Read Post »
Health TidingsTeva Submits FDA Application for Ecopipam in Pediatric Tourette Syndrome Teva Submits FDA Application for Ecopipam in Pediatric Tourette Syndrome Read Post »
Health TidingsFDA Panel Votes 9-0 in Support of Moderna’s mRNA Flu Vaccine FDA Panel Votes 9-0 in Support of Moderna’s mRNA Flu Vaccine Read Post »
Generics Mergers & AcquisitionsSamsung Bioepis and Organon Expand Canadian Biosimilar Portfolio with PYZCH... Samsung Bioepis and Organon Expand Canadian Biosimilar Portfolio with PYZCH... Read Post »
Health TidingsZabopegdutide Demonstrates Robust Fibrosis Reduction in MASH Trial Zabopegdutide Demonstrates Robust Fibrosis Reduction in MASH Trial Read Post »
Health Tidings Mergers & AcquisitionsVoro and Alloy Partner to Develop Safer T-Cell Engager Therapies Voro and Alloy Partner to Develop Safer T-Cell Engager Therapies Read Post »
Health TidingsNovocure’s Phase 3 TRIDENT Trial Misses Survival Endpoint in Glioblastoma... Novocure’s Phase 3 TRIDENT Trial Misses Survival Endpoint in Glioblastoma... Read Post »
Health TidingsFDA Accepts Lunsumio VELO Plus Polivy Application After Strong Phase 3 SUNM... FDA Accepts Lunsumio VELO Plus Polivy Application After Strong Phase 3 SUNM... Read Post »
Health Tidings Mergers & AcquisitionsBiogen to Acquire RayThera in Up to $1 Billion Deal, Expanding Immunology P... Biogen to Acquire RayThera in Up to $1 Billion Deal, Expanding Immunology P... Read Post »
GenericsFDA Approves First Generic Xofluza for Influenza Treatment and Prevention FDA Approves First Generic Xofluza for Influenza Treatment and Prevention Read Post »
Health TidingsOcular Aligns with FDA on AXPAXLI NDA Submission for Wet AMD, Targets Filin... Ocular Aligns with FDA on AXPAXLI NDA Submission for Wet AMD, Targets Filin... Read Post »
Health TidingsFDA Grants Orphan Status to Sernova’s Cell Pouch in Post-Pancreatecto... FDA Grants Orphan Status to Sernova’s Cell Pouch in Post-Pancreatecto... Read Post »
Health TidingsFDA Grants Fast Track Status to NovaBridge’s Givastomig FDA Grants Fast Track Status to NovaBridge’s Givastomig Read Post »
Health TidingsModerna Targets New Vaccine, Oncology, and Rare Disease Launches Through 20... Moderna Targets New Vaccine, Oncology, and Rare Disease Launches Through 20... Read Post »
