Drugs Safety AlertFDA Adds New Safety Warning to ALTUVIIIO Label FDA Adds New Safety Warning to ALTUVIIIO Label Read Post »
Clinical TrialsIncyte’s INCA033989 Delivers Durable Responses in CALR-Mutated MPNs at EH... Incyte’s INCA033989 Delivers Durable Responses in CALR-Mutated MPNs at EH... Read Post »
Clinical TrialsZilurgisertib Cuts New Bone Formation in FOP, FDA Grants Priority Review Zilurgisertib Cuts New Bone Formation in FOP, FDA Grants Priority Review Read Post »
Clinical TrialsJaypirca Regimen Cuts Progression Risk by 45% in Relapsed CLL Jaypirca Regimen Cuts Progression Risk by 45% in Relapsed CLL Read Post »
Clinical TrialsSun Pharma’s UNLOXCYT™ Delivers Durable Responses in Advanced CSCC Sun Pharma’s UNLOXCYT™ Delivers Durable Responses in Advanced CSCC Read Post »
Health TidingsMHRA Clears Lower-Dose EURneffy for Children at Risk of Anaphylaxis MHRA Clears Lower-Dose EURneffy for Children at Risk of Anaphylaxis Read Post »
Health TidingsTalquetamab Regimens Deliver Strong Survival Gains in Relapsed Myeloma Talquetamab Regimens Deliver Strong Survival Gains in Relapsed Myeloma Read Post »
Health TidingsLonvo-z Demonstrates Significant Attack Reduction in Hereditary Angioedema Lonvo-z Demonstrates Significant Attack Reduction in Hereditary Angioedema Read Post »
Clinical TrialsSetmelanotide Lowers BMI and Improves Hyperphagia in Prader-Willi Syndrome Setmelanotide Lowers BMI and Improves Hyperphagia in Prader-Willi Syndrome Read Post »
Clinical TrialsAgios Presents Phase 3 RISE UP Results for Mitapivat in Sickle Cell Disease... Agios Presents Phase 3 RISE UP Results for Mitapivat in Sickle Cell Disease... Read Post »
Clinical TrialsfrontMIND Trial Meets Primary Endpoint in High-Risk DLBCL and HGBL frontMIND Trial Meets Primary Endpoint in High-Risk DLBCL and HGBL Read Post »
Health TidingsFDA Approves First PTEN Companion Diagnostic for TRUQAP in Prostate Cancer FDA Approves First PTEN Companion Diagnostic for TRUQAP in Prostate Cancer Read Post »
Medical DevicesFirst Over-the-Counter CGM Wins FDA Approval for Pediatric Use First Over-the-Counter CGM Wins FDA Approval for Pediatric Use Read Post »
Health TidingsFDA Grants Accelerated Approval to Tzield for Children with Stage 3 T1D FDA Grants Accelerated Approval to Tzield for Children with Stage 3 T1D Read Post »
Health TidingsFDA Approves Truqap for PTEN-Deficient Metastatic Prostate Cancer FDA Approves Truqap for PTEN-Deficient Metastatic Prostate Cancer Read Post »
New Drug ApprovalFDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... FDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... Read Post »
New Drug ApprovalUK Approves Europe’s First Oral Wegovy for Weight Management UK Approves Europe’s First Oral Wegovy for Weight Management Read Post »
New Drug ApprovalAkeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Akeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Read Post »
Drugs Safety AlertPRAC Finds Inconsistent Evidence on Paternal Valproate Risk in Children PRAC Finds Inconsistent Evidence on Paternal Valproate Risk in Children Read Post »
Mergers & AcquisitionsRichter and Hetero Team Up on Generic Semaglutide for Global Markets Richter and Hetero Team Up on Generic Semaglutide for Global Markets Read Post »
Health TidingsBeOne Reports Strong Tacabrutideg and ZS Outcomes in CLL, MCL, and WM BeOne Reports Strong Tacabrutideg and ZS Outcomes in CLL, MCL, and WM Read Post »
Health TidingsBioCryst Reports Long-Term ORLADEYO Benefits and New Navenibart Data in HAE BioCryst Reports Long-Term ORLADEYO Benefits and New Navenibart Data in HAE Read Post »
Clinical TrialsNovartis’ Rhapsido Delivers Positive Phase 3 Results in CIU Novartis’ Rhapsido Delivers Positive Phase 3 Results in CIU Read Post »
Clinical TrialsCogent Advances Bezuclastinib Toward NDA Submission With Positive APEX Resu... Cogent Advances Bezuclastinib Toward NDA Submission With Positive APEX Resu... Read Post »
Clinical TrialsJazz’s Phase 3 LAGOON Trial Fails to Improve Survival in Relapsed SCL... Jazz’s Phase 3 LAGOON Trial Fails to Improve Survival in Relapsed SCL... Read Post »
Lifestyle WellnessGalderma Survey Shows Long-Lasting Results Drive Anti-Wrinkle Treatment Dec... Galderma Survey Shows Long-Lasting Results Drive Anti-Wrinkle Treatment Dec... Read Post »
Clinical TrialsVenetoclax Plus Obinutuzumab Cuts Risk of Progression or Death by 50% in CL... Venetoclax Plus Obinutuzumab Cuts Risk of Progression or Death by 50% in CL... Read Post »
Health TidingsGSK Secures Orphan Drug Designations in US and EU for Momelotinib in VEXAS ... GSK Secures Orphan Drug Designations in US and EU for Momelotinib in VEXAS ... Read Post »
Clinical TrialsGenmab’s Epcoritamab Plus R2 Maintains Strong Benefit Across Risk Gro... Genmab’s Epcoritamab Plus R2 Maintains Strong Benefit Across Risk Gro... Read Post »
Health TidingsCaliway’s CBL-514 Cuts Weight Regain When Added to Tirzepatide in Pre... Caliway’s CBL-514 Cuts Weight Regain When Added to Tirzepatide in Pre... Read Post »
Clinical TrialsCullinan Reports Promising Phase 1 Results for CLN-978 and Velinotamig Cullinan Reports Promising Phase 1 Results for CLN-978 and Velinotamig Read Post »
Clinical TrialsFDA Backs Phase 3 Plan as Enliven Posts Strong Phase 1 CML Results FDA Backs Phase 3 Plan as Enliven Posts Strong Phase 1 CML Results Read Post »
Health TidingsNovartis Reports Positive FORTITUDE Data for Del-Brax in FSHD Novartis Reports Positive FORTITUDE Data for Del-Brax in FSHD Read Post »
Health TidingsTakeda Reports Phase 3 Win for Zasocitinib in Plaque Psoriasis Takeda Reports Phase 3 Win for Zasocitinib in Plaque Psoriasis Read Post »
Health TidingsCASGEVY Extends Durable Clinical Benefit to Children With SCD and TDT CASGEVY Extends Durable Clinical Benefit to Children With SCD and TDT Read Post »
Health TidingsCemsidomide Achieves 53% Response Rate in Phase 1/2 Multiple Myeloma Trial Cemsidomide Achieves 53% Response Rate in Phase 1/2 Multiple Myeloma Trial Read Post »
Clinical TrialsZiftomenib + 7+3 Achieves 94% One-Year Survival in NPM1-Mutant AML in KOMET... Ziftomenib + 7+3 Achieves 94% One-Year Survival in NPM1-Mutant AML in KOMET... Read Post »
Clinical TrialsSix-Year SEQUOIA Data Highlight Durable BRUKINSA Benefit in CLL Patients Ag... Six-Year SEQUOIA Data Highlight Durable BRUKINSA Benefit in CLL Patients Ag... Read Post »
Clinical TrialsJohnson & Johnson Strengthens IMAAVY FDA Filing With Positive ENERGY Re... Johnson & Johnson Strengthens IMAAVY FDA Filing With Positive ENERGY Re... Read Post »
Health TidingsFDA Delays CAM2029 Approval in Acromegaly Over Manufacturing Issues FDA Delays CAM2029 Approval in Acromegaly Over Manufacturing Issues Read Post »
Health TidingsFDA Grants Priority Review to Roche’s Tecentriq in Early-Stage Colon Canc... FDA Grants Priority Review to Roche’s Tecentriq in Early-Stage Colon Canc... Read Post »
Health Tidings Mergers & AcquisitionsServier, n-Lorem Launch ASO Research Partnership in Rare Neurology Servier, n-Lorem Launch ASO Research Partnership in Rare Neurology Read Post »
Health Tidings Mergers & AcquisitionsNovartis Expands Orionis Partnership in $1.4 Billion Molecular Glue Drug Di... Novartis Expands Orionis Partnership in $1.4 Billion Molecular Glue Drug Di... Read Post »
Health TidingsOno Files VELEXBRU Expansion in Japan for Secondary CNS Lymphoma Ono Files VELEXBRU Expansion in Japan for Secondary CNS Lymphoma Read Post »
New Drug ApprovalFDA Expands Organon’s TOFIDENCE Biosimilar Approval to CAR-T CRS and COVI... FDA Expands Organon’s TOFIDENCE Biosimilar Approval to CAR-T CRS and COVI... Read Post »
Drugs Safety AlertFDA Updates Alli Label to Warn of Rare Risk of Acute Kidney Injury and Kidn... FDA Updates Alli Label to Warn of Rare Risk of Acute Kidney Injury and Kidn... Read Post »
Health TidingsWhat Zepbound and Shaquille O’Neal’s Story Reveal About Undiagn... What Zepbound and Shaquille O’Neal’s Story Reveal About Undiagn... Read Post »
Health TidingsEMA Begins Review of Bayer’s Asundexian for Secondary Stroke Prevention EMA Begins Review of Bayer’s Asundexian for Secondary Stroke Prevention Read Post »
Clinical TrialsSanofi Halts Phase 3 MOBILIZE Trial of Riliprubart in Refractory CIDP Sanofi Halts Phase 3 MOBILIZE Trial of Riliprubart in Refractory CIDP Read Post »
Health TidingsFDA Accepts Takeda’s ENTYVIO sBLA for Pediatric Ulcerative Colitis and Cr... FDA Accepts Takeda’s ENTYVIO sBLA for Pediatric Ulcerative Colitis and Cr... Read Post »
Health TidingsBausch Health Secures Key Reimbursement Milestone for PrOKEDI in Canada Bausch Health Secures Key Reimbursement Milestone for PrOKEDI in Canada Read Post »
