Health TidingsFDA Grants Priority Review to Bayer’s Kerendia for T1D-Associated CKD FDA Grants Priority Review to Bayer’s Kerendia for T1D-Associated CKD Read Post »
Health Tidings Mergers & AcquisitionsBMS Integrates Claude AI into Research, Clinical Development, and Manufactu... BMS Integrates Claude AI into Research, Clinical Development, and Manufactu... Read Post »
Health TidingsFDA Backs Cullinan Therapeutics’ CLN-049 With Orphan Drug Status in AML FDA Backs Cullinan Therapeutics’ CLN-049 With Orphan Drug Status in AML Read Post »
Health TidingsPfizer’s 25vPnC Shows Improved Serotype 3 Protection in Infant Phase 2 St... Pfizer’s 25vPnC Shows Improved Serotype 3 Protection in Infant Phase 2 St... Read Post »
Health TidingsImmunityBio’s ANKTIVA sBLA for Papillary NMIBC Accepted by FDA ImmunityBio’s ANKTIVA sBLA for Papillary NMIBC Accepted by FDA Read Post »
Health TidingsNovo Nordisk Highlights New Semaglutide Data in MASH Ahead of EASL 2026 Novo Nordisk Highlights New Semaglutide Data in MASH Ahead of EASL 2026 Read Post »
GenericsSamsung Bioepis Launches Ustekinumab Biosimilar in Japan With NIPRO Samsung Bioepis Launches Ustekinumab Biosimilar in Japan With NIPRO Read Post »
Health TidingsBayer Files Asundexian in U.S. and Japan After Positive Phase III Stroke Da... Bayer Files Asundexian in U.S. and Japan After Positive Phase III Stroke Da... Read Post »
Health TidingsLantern Advances LP-300 Program After FDA Backs HARMONIC Trial Amendments Lantern Advances LP-300 Program After FDA Backs HARMONIC Trial Amendments Read Post »
Health TidingsTakeda Faces $885 Million Jury Verdict in AMITIZA Antitrust Case Takeda Faces $885 Million Jury Verdict in AMITIZA Antitrust Case Read Post »
Health TidingsImmunityBio Expands ANKTIVA Patent Protection in NMIBC Through 2035 ImmunityBio Expands ANKTIVA Patent Protection in NMIBC Through 2035 Read Post »
Health TidingsFDA Prioritizes Review of Bayer’s Sevabertinib for HER2-Mutant NSCLC FDA Prioritizes Review of Bayer’s Sevabertinib for HER2-Mutant NSCLC Read Post »
Health TidingsApnimed’s AD109 Shows Sustained Sleep Apnea Improvements Through 26 Weeks Apnimed’s AD109 Shows Sustained Sleep Apnea Improvements Through 26 Weeks Read Post »
Health TidingsFDA Accepts Viatris NDA for Fast-Acting Meloxicam in Acute Pain FDA Accepts Viatris NDA for Fast-Acting Meloxicam in Acute Pain Read Post »
Health Tidings Mergers & AcquisitionsImmunityBio Secures Exclusive U.S. Rights to Tokyo-172 BCG for Bladder Canc... ImmunityBio Secures Exclusive U.S. Rights to Tokyo-172 BCG for Bladder Canc... Read Post »
GenericsAlteogen Secures Korean Approval for EYZANFY in Retinal Diseases Alteogen Secures Korean Approval for EYZANFY in Retinal Diseases Read Post »
GenericsApotex Launches Generic Ozempic Equivalent Apo-Semaglutide in Canada Apotex Launches Generic Ozempic Equivalent Apo-Semaglutide in Canada Read Post »
GenericsSandoz Wins EU Approval for Bysumlog and Dazparda Biosimilar Insulins Sandoz Wins EU Approval for Bysumlog and Dazparda Biosimilar Insulins Read Post »
Health TidingsAstellas Secures China NDA Acceptance and Priority Review for IZERVAY in Ge... Astellas Secures China NDA Acceptance and Priority Review for IZERVAY in Ge... Read Post »
Health TidingsAstellas Seeks Japan Approval for PADCEV-Keytruda Perioperative Regimen Astellas Seeks Japan Approval for PADCEV-Keytruda Perioperative Regimen Read Post »
Health TidingsAardvark ARD-101 Program Placed on Full FDA Clinical Hold in Prader-Willi S... Aardvark ARD-101 Program Placed on Full FDA Clinical Hold in Prader-Willi S... Read Post »
Health TidingsNICE Approves AstraZeneca’s Durvalumab for Aggressive Stomach Cancer NICE Approves AstraZeneca’s Durvalumab for Aggressive Stomach Cancer Read Post »
Health Tidings Mergers & AcquisitionsEli Lilly and UNICEF USA Strengthen Childhood NCD Care in LMICs Eli Lilly and UNICEF USA Strengthen Childhood NCD Care in LMICs Read Post »
Health TidingsChugai and Nippon Shinyaku Seek Japan Approval for Gazyva in Nephrotic Synd... Chugai and Nippon Shinyaku Seek Japan Approval for Gazyva in Nephrotic Synd... Read Post »
Health TidingsIpsen Presents Phase II LANTIC Data for Corabotase in Glabellar Lines at SC... Ipsen Presents Phase II LANTIC Data for Corabotase in Glabellar Lines at SC... Read Post »
Health TidingsFDA Grants Fast Track Designation to XPro1595 for Early Alzheimer’s Disea... FDA Grants Fast Track Designation to XPro1595 for Early Alzheimer’s Disea... Read Post »
GenericsLupin Receives FDA Approval for Generic Famotidine Injection Lupin Receives FDA Approval for Generic Famotidine Injection Read Post »
Health Tidings Mergers & AcquisitionsEnodia Therapeutics Acquires Sec61-Based Assets from Kezar Life Sciences Enodia Therapeutics Acquires Sec61-Based Assets from Kezar Life Sciences Read Post »
Health TidingsCoya Therapeutics Secures FDA Fast Track Tag for COYA 302 in ALS Coya Therapeutics Secures FDA Fast Track Tag for COYA 302 in ALS Read Post »
Health TidingsGyre Gains NMPA NDA Acceptance for F351 Liver Fibrosis Therapy Gyre Gains NMPA NDA Acceptance for F351 Liver Fibrosis Therapy Read Post »
Health TidingsAgios Targets Accelerated Approval for Mitapivat in Sickle Cell Disease Agios Targets Accelerated Approval for Mitapivat in Sickle Cell Disease Read Post »
Health TidingsServier’s Emi-Le Receives FDA Breakthrough Therapy Designation for Adenoi... Servier’s Emi-Le Receives FDA Breakthrough Therapy Designation for Adenoi... Read Post »
ManufacturingMacroGenics Hands Bora the Keys to Its Maryland Manufacturing Engine MacroGenics Hands Bora the Keys to Its Maryland Manufacturing Engine Read Post »
Health Tidings Mergers & AcquisitionsBMS and Hengrui Forge a $15.2 Billion Drug Discovery Alliance BMS and Hengrui Forge a $15.2 Billion Drug Discovery Alliance Read Post »
GenericsTranspire Stakes Its Claim in the Generic Trelegy Ellipta Race Transpire Stakes Its Claim in the Generic Trelegy Ellipta Race Read Post »
Health Tidings Mergers & AcquisitionsGSK Aligns With CTTQ to Expand Access to Bepirovirsen in China GSK Aligns With CTTQ to Expand Access to Bepirovirsen in China Read Post »
Health Tidings Mergers & AcquisitionsOncotelic-Lunai N2B Deal Gains Momentum Amid Rising Focus on CNS Drug Deliv... Oncotelic-Lunai N2B Deal Gains Momentum Amid Rising Focus on CNS Drug Deliv... Read Post »
Health TidingsZai Lab Puts Zoci on the Fast Track in the Race Against epNEC Zai Lab Puts Zoci on the Fast Track in the Race Against epNEC Read Post »
Health TidingsInnovent Biologics Moves IBI363 Into Phase III After China Breakthrough Nod Innovent Biologics Moves IBI363 Into Phase III After China Breakthrough Nod Read Post »
Health TidingsMoonLake Aligns with FDA on BLA Strategy for SLK in Hidradenitis Suppurativ... MoonLake Aligns with FDA on BLA Strategy for SLK in Hidradenitis Suppurativ... Read Post »
Health TidingsServier and Day One Complete Enrollment in Phase 3 OJEMDA Glioma Trial Servier and Day One Complete Enrollment in Phase 3 OJEMDA Glioma Trial Read Post »
Health TidingsCapricor Files Lawsuit Against NS Pharma Over Deramiocel Access Capricor Files Lawsuit Against NS Pharma Over Deramiocel Access Read Post »
Health TidingsEisai and Biogen Face Three-Month FDA Delay for LEQEMBI sBLA Eisai and Biogen Face Three-Month FDA Delay for LEQEMBI sBLA Read Post »
Health TidingsAtara and Pierre Fabre Aligns with FDA on Tab-cel BLA Resubmission Path Atara and Pierre Fabre Aligns with FDA on Tab-cel BLA Resubmission Path Read Post »
Health TidingsBayer Wins China Priority Review for Asundexian in Stroke Prevention Bayer Wins China Priority Review for Asundexian in Stroke Prevention Read Post »
Health TidingsAvalo Reports Positive Phase 2 Results for Abdakibart in HS Avalo Reports Positive Phase 2 Results for Abdakibart in HS Read Post »
Health TidingsBIZENGRI Receives FDA Priority Voucher in NRG1+ Cholangiocarcinoma BIZENGRI Receives FDA Priority Voucher in NRG1+ Cholangiocarcinoma Read Post »
Health Tidings Mergers & AcquisitionsGSK Partners With Halozyme to Develop Subcutaneous ADC Therapies GSK Partners With Halozyme to Develop Subcutaneous ADC Therapies Read Post »
Health TidingsMHRA Intensifies Operation Pangea Crackdown on Illegal Medicines MHRA Intensifies Operation Pangea Crackdown on Illegal Medicines Read Post »
Health Tidings Mergers & AcquisitionsGSK Licenses SiranBio’s siRNA Candidate SA030 in Up to $1 Billion Deal GSK Licenses SiranBio’s siRNA Candidate SA030 in Up to $1 Billion Deal Read Post »
