📁 All Events (14673 stories)
Incyte's Monjuvi combo demonstrated positive phase 3 results across patient subgroups for first-line diffuse B-cell lymphoma (DLBCL). The company aims to position Monjuvi as a competitive option against the standard R-CHOP regimen and Roche's Polivy, ahead of newer T-cell engagers.
Incyte's Monjuvi combo demonstrated positive phase 3 results across patient subgroups for first-line diffuse B-cell lymphoma (DLBCL). The company aims to position Monjuvi as a competitive option against the standard R-CHOP regimen and Roche's Polivy, ahead of newer T-cell engagers.
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The FDA has 11 upcoming PDUFA dates in June. These dates involve decisions for at least eight new products and three new indications.
The FDA has 11 upcoming PDUFA dates in June. These dates involve decisions for at least eight new products and three new indications.
Precigen presented new long-term durability data for PAPZIMEOS, demonstrating that 83% (15 out of 18) of complete responders maintained responses for at least 36 months in RRP patients. Five complete responders showed ongoing responses beyond 4 years, with the median duration of complete response not yet reached. PAPZIMEOS recently received seven-year market exclusivity.
Precigen presented new long-term durability data for PAPZIMEOS, demonstrating that 83% (15 out of 18) of complete responders maintained responses for at least 36 months in RRP patients. Five complete responders showed ongoing responses beyond 4 years, with the median duration of complete response no
complete_responders_percentage83%complete_responders_count_36m15 out of 18complete_responders_count_4y5
Gilead has abandoned its lead rheumatoid arthritis drug, which originated from its $405 million acquisition of MiroBio. This decision marks a setback for the BTLA agonist field.
Gilead has abandoned its lead rheumatoid arthritis drug, which originated from its $405 million acquisition of MiroBio. This decision marks a setback for the BTLA agonist field.
AstraZeneca's drug candidate anselamimab failed its primary endpoint in a Phase 3 trial for a rare disease. Despite the initial miss, the company has released prespecified subgroup data showing a 62% improvement in survival. AstraZeneca believes this subgroup data can support a pitch for regulatory approval.
AstraZeneca's drug candidate anselamimab failed its primary endpoint in a Phase 3 trial for a rare disease. Despite the initial miss, the company has released prespecified subgroup data showing a 62% improvement in survival. AstraZeneca believes this subgroup data can support a pitch for regulatory
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A 7-year update from the phase 3 CROWN study on lorlatinib versus crizotinib as first-line treatment for advanced ALK-positive non-small cell lung cancer was presented. The study previously demonstrated an unprecedented progression-free survival benefit with lorlatinib after 5 years of follow-up, and the current update aims to quantify long-term outcomes at 7 years.
A 7-year update from the phase 3 CROWN study on lorlatinib versus crizotinib as first-line treatment for advanced ALK-positive non-small cell lung cancer was presented. The study previously demonstrated an unprecedented progression-free survival benefit with lorlatinib after 5 years of follow-up, an
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A randomized controlled trial involving 213 adults with stable ischemic heart disease (IHD) and elevated pressure pain sensitivity (PPS) evaluated a PPS-guided non-pharmacological intervention. The active group received three months of structured education. The intervention successfully lowered cardiovascular event rates after five years in IHD patients.
A randomized controlled trial involving 213 adults with stable ischemic heart disease (IHD) and elevated pressure pain sensitivity (PPS) evaluated a PPS-guided non-pharmacological intervention. The active group received three months of structured education. The intervention successfully lowered card
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In an interim analysis of the OptiTROP-Lung05 phase 3 trial, sacituzumab tirumotecan plus pembrolizumab significantly prolonged progression-free survival compared to pembrolizumab alone. This was observed in patients with PD-L1-positive advanced NSCLC without targetable genomic alterations. The combination has the potential to redefine first-line treatment for this patient population.
In an interim analysis of the OptiTROP-Lung05 phase 3 trial, sacituzumab tirumotecan plus pembrolizumab significantly prolonged progression-free survival compared to pembrolizumab alone. This was observed in patients with PD-L1-positive advanced NSCLC without targetable genomic alterations. The comb
complete_responders_percentage83%complete_responders_count_36m15 out of 18complete_responders_count_4y5
New data for TECVAYLI® (teclistamab-cqyv) demonstrate superior progression-free and overall survival as early as first relapse in multiple myeloma. The MajesTEC-9 study, a positive Phase 3 trial by Johnson & Johnson, reinforced TECVAYLI®'s strength as early as second line, showing deep and durable responses.
New data for TECVAYLI® (teclistamab-cqyv) demonstrate superior progression-free and overall survival as early as first relapse in multiple myeloma. The MajesTEC-9 study, a positive Phase 3 trial by Johnson & Johnson, reinforced TECVAYLI®'s strength as early as second line, showing deep and durable r
complete_responders_percentage83%complete_responders_count_36m15 out of 18complete_responders_count_4y5
Dizal announced positive Phase 3 WU-KONG28 results for ZEGFROVY® (Sunvozertinib). The drug demonstrated superior anti-tumor efficacy compared to platinum-doublet chemotherapy as a first-line treatment for advanced EGFR exon 20 insertion mutation-positive NSCLC. This marks the first global randomized phase 3 study with positive results for an oral, chemo-free, targeted monotherapy regimen in this indication.
Dizal announced positive Phase 3 WU-KONG28 results for ZEGFROVY® (Sunvozertinib). The drug demonstrated superior anti-tumor efficacy compared to platinum-doublet chemotherapy as a first-line treatment for advanced EGFR exon 20 insertion mutation-positive NSCLC. This marks the first global randomized
complete_responders_percentage83%complete_responders_count_36m15 out of 18complete_responders_count_4y5
The FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) on May 28, 2026. This approval is for adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
The FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) on May 28, 2026. This approval is for adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
The FDA has approved a label expansion for TREMFYA®, an IL-23 inhibitor from Johnson & Johnson. This approval is for adults with active psoriatic arthritis, based on data showing significant inhibition of structural joint damage.
The FDA has approved a label expansion for TREMFYA®, an IL-23 inhibitor from Johnson & Johnson. This approval is for adults with active psoriatic arthritis, based on data showing significant inhibition of structural joint damage.
The FDA has approved pivekimab sunirine-pvzy for the treatment of blastic plasmacytoid dendritic cell neoplasm. This condition is an ultra-rare hematologic malignancy.
The FDA has approved pivekimab sunirine-pvzy for the treatment of blastic plasmacytoid dendritic cell neoplasm. This condition is an ultra-rare hematologic malignancy.
Sun Pharma is set to present pivotal long-term follow-up data for UNLOXCYT (cosibelimab-ipdl) at the ASCO 2026 Annual Meeting. The data indicates nearly 27% of patients experienced a complete response, with the median duration of response not yet reached. Only one patient experienced a Grade >3 immune-related adverse event in this study for locally advanced cutaneous squamous cell carcinoma.
Sun Pharma is set to present pivotal long-term follow-up data for UNLOXCYT (cosibelimab-ipdl) at the ASCO 2026 Annual Meeting. The data indicates nearly 27% of patients experienced a complete response, with the median duration of response not yet reached. Only one patient experienced a Grade >3 immu
complete_responders_percentage83%complete_responders_count_36m15 out of 18complete_responders_count_4y5
Emalex Biosciences plans to seek FDA approval for ecopipam, a drug designed to treat children with motor and vocal tics associated with Tourette Syndrome. Data from a Phase III clinical trial, led by Cincinnati Children's, showed that continued use of ecopipam can cut the risk of relapse.
Emalex Biosciences plans to seek FDA approval for ecopipam, a drug designed to treat children with motor and vocal tics associated with Tourette Syndrome. Data from a Phase III clinical trial, led by Cincinnati Children's, showed that continued use of ecopipam can cut the risk of relapse.
complete_responders_percentage83%complete_responders_count_36m15 out of 18complete_responders_count_4y5
The EMA's CHMP has issued a positive opinion recommending approval of Pierre Fabre Laboratories' Braftovi. This drug is intended to treat mCRC in patients with BRAFV600E mutations.
The EMA's CHMP has issued a positive opinion recommending approval of Pierre Fabre Laboratories' Braftovi. This drug is intended to treat mCRC in patients with BRAFV600E mutations.
AstraZeneca and Daiichi Sankyo have received FDA approval for their drug Datroway (datopotamab deruxtecan). The approval is for the treatment of metastatic triple-negative breast cancer (TNBC).
AstraZeneca and Daiichi Sankyo have received FDA approval for their drug Datroway (datopotamab deruxtecan). The approval is for the treatment of metastatic triple-negative breast cancer (TNBC).