📁 All Events (14561 stories)
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
ORRstatistically significant improvement
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
The FDA has approved datopotamab deruxtecan-dlnk. This approval is for the treatment of unresectable or metastatic triple-negative breast cancer.
The FDA has approved datopotamab deruxtecan-dlnk. This approval is for the treatment of unresectable or metastatic triple-negative breast cancer.
The U.S. Food and Drug Administration (FDA) has approved Hepcludex (bulevirtide-gmod) injection. This marks the first treatment for chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.
The U.S. Food and Drug Administration (FDA) has approved Hepcludex (bulevirtide-gmod) injection. This marks the first treatment for chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.
EMA Approval: Deqtynet (CIS bio international)
Active substance: oxodotreotide | EC Decision: 21/05/2026 | Status: Opinion | Flags: Orphan | Area: Radionuclide Imaging | Papers: Italian Association of Nuclear Medicine, Molecular Imaging and Therapy (AIMN) pr (Clinical and translational imaging 2025); The experience of a nuclear physician in deve
ORRstatistically significant improvement
A phase I study evaluating capmatinib plus trametinib in metastatic MET-driven NSCLC patients who progressed on prior MET inhibitors was terminated early. The study enrolled three patients, all of whom discontinued therapy due to significant treatment-related adverse events. No objective responses were observed, and further investigation of this combination is not recommended.
A phase I study evaluating capmatinib plus trametinib in metastatic MET-driven NSCLC patients who progressed on prior MET inhibitors was terminated early. The study enrolled three patients, all of whom discontinued therapy due to significant treatment-related adverse events. No objective responses w
BioMarin's dwarfism drug Voxzogo achieved positive Phase 3 results in a hypochondroplasia study, exceeding the company's expectations. Based on these successful outcomes, BioMarin plans to file for a label expansion for Voxzogo.
BioMarin's dwarfism drug Voxzogo achieved positive Phase 3 results in a hypochondroplasia study, exceeding the company's expectations. Based on these successful outcomes, BioMarin plans to file for a label expansion for Voxzogo.
Eli Lilly's triple-G drug retatrutide met its primary endpoint for weight loss in a Phase 3 obesity trial. Patients treated with the drug lost roughly a quarter of their weight, demonstrating competitive efficacy and tolerability.
Eli Lilly's triple-G drug retatrutide met its primary endpoint for weight loss in a Phase 3 obesity trial. Patients treated with the drug lost roughly a quarter of their weight, demonstrating competitive efficacy and tolerability. | Endpoints: weight loss: roughly a quarter of weight
Kelun-Biotech announced that its Phase III clinical study (OptiTROP-Breast03) of Sacituzumab Tirumotecan (sac-TMT) as a first-line treatment for advanced TNBC met its primary endpoint of PFS. The Independent Data Monitoring Committee (IDMC) concluded the positive outcome.
Kelun-Biotech announced that its Phase III clinical study (OptiTROP-Breast03) of Sacituzumab Tirumotecan (sac-TMT) as a first-line treatment for advanced TNBC met its primary endpoint of PFS. The Independent Data Monitoring Committee (IDMC) concluded the positive outcome.
ApolloBio, INOVIO's partner in China, announced positive topline results from a Phase 3 trial for VGX-3100 in cervical dysplasia patients. These results provide clinical evidence to support ApolloBio's future regulatory submission in China for VGX-3100.
ApolloBio, INOVIO's partner in China, announced positive topline results from a Phase 3 trial for VGX-3100 in cervical dysplasia patients. These results provide clinical evidence to support ApolloBio's future regulatory submission in China for VGX-3100.
Sobi announced positive topline results from the pivotal Phase 3 REDUCE 2 study of pozdeutinurad (AR882) in gout. Both doses of once-daily pozdeutinurad met the primary efficacy endpoint of sUA reduction at month 6 vs placebo and were overall well tolerated.
Sobi announced positive topline results from the pivotal Phase 3 REDUCE 2 study of pozdeutinurad (AR882) in gout. Both doses of once-daily pozdeutinurad met the primary efficacy endpoint of sUA reduction at month 6 vs placebo and were overall well tolerated.
Rigel announced upcoming oral and poster presentations at the 2026 ASCO Annual Meeting and EHA2026 Congress. The presentations will feature final data from the Phase 3 AcceleRET-Lung clinical trial of GAVRETO (pralsetinib) for first-line treatment in RET fusion-positive NSCLC, as well as final analysis from the Phase 1/2 ARROW clinical trial of pralsetinib.
Rigel announced upcoming oral and poster presentations at the 2026 ASCO Annual Meeting and EHA2026 Congress. The presentations will feature final data from the Phase 3 AcceleRET-Lung clinical trial of GAVRETO (pralsetinib) for first-line treatment in RET fusion-positive NSCLC, as well as final analy
The FDA has approved a first-in-class drug for hypertension. The approval was published online on May 20, 2026.
The FDA has approved a first-in-class drug for hypertension. The approval was published online on May 20, 2026.
Tebentafusp demonstrated an overall survival benefit in a phase 3 trial for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. It is now the first-line standard of care for this population, with the final 5-year overall survival analysis reported.
Tebentafusp demonstrated an overall survival benefit in a phase 3 trial for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. It is now the first-line standard of care for this population, with the final 5-year overall survival analysis reported. | Endpoints: overal
BioMarin Pharmaceutical's enzyme replacement therapy for ENPP1 deficiency showed no clinical benefit in a Phase 3 study. The late-stage trial delivered mixed results for the rare genetic disorder.
BioMarin Pharmaceutical's enzyme replacement therapy for ENPP1 deficiency showed no clinical benefit in a Phase 3 study. The late-stage trial delivered mixed results for the rare genetic disorder.
The FDA's April approvals included a slimmer label for Xpovio, two New Molecular Entities (NMEs), and a gene therapy. An sNDA removed Xpovio's accelerated approval for DLBCL.
The FDA's April approvals included a slimmer label for Xpovio, two New Molecular Entities (NMEs), and a gene therapy. An sNDA removed Xpovio's accelerated approval for DLBCL.
AstraZeneca received FDA approval for its aldosterone synthase inhibitor (ASI) baxdrostat for hypertension. This approval follows an impressive phase 3 showing and contributes to AstraZeneca's goal of reaching $80 billion in revenue by the end of the decade. Additionally, Fasenra also received an approval sweetener.
AstraZeneca received FDA approval for its aldosterone synthase inhibitor (ASI) baxdrostat for hypertension. This approval follows an impressive phase 3 showing and contributes to AstraZeneca's goal of reaching $80 billion in revenue by the end of the decade. Additionally, Fasenra also received an ap