📁 All Events (14663 stories)
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
PFSsignificantly prolonged
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
PFSsignificantly prolonged
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
PFSsignificantly prolonged
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
PFSsignificantly prolonged
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
PFSsignificantly prolonged
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
PFSsignificantly prolonged
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
PFSsignificantly prolonged
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.
PFSsignificantly prolonged
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).
Pierre Fabre Laboratories received a positive CHMP opinion for BRAFTOVI® (encorafenib) in combination with Cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC). This opinion is based on the Phase 3 BREAKWATER study, which demonstrated a statistically significant improvement in primary endpoints, including objective response rate (ORR).
Pierre Fabre Laboratories received a positive CHMP opinion for BRAFTOVI® (encorafenib) in combination with Cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC). This opinion is based on the Phase 3 BREAKWATER study, which demo
The US Food and Drug Administration (FDA) has approved a new medication. This medication is indicated for the treatment of agitation associated with dementia due to Alzheimer disease.
The US Food and Drug Administration (FDA) has approved a new medication. This medication is indicated for the treatment of agitation associated with dementia due to Alzheimer disease.
Merck & Co. and Kelun-Biotech's sac-TMT reported positive results from three Phase 3 trials. Experts highlighted the importance of local know-how, due diligence, and AI for successful licensing deals in China. Separately, a federal jury found a drugmaker liable in a pay-for-delay case for the first time.
Merck & Co. and Kelun-Biotech's sac-TMT reported positive results from three Phase 3 trials. Experts highlighted the importance of local know-how, due diligence, and AI for successful licensing deals in China. Separately, a federal jury found a drugmaker liable in a pay-for-delay case for the first
PFSsignificantly prolonged