⚡ Top Events Today
AstraZeneca & Daiichi Sankyo Secure FDA Approval for ADC Datroway in mTNBC
The FDA has approved the antibody-drug conjugate (ADC) for the treatment of metastatic triple-negative breast cancer.
AbbVie Gains FDA Nod for ImmunoGen-Acquired Asset in Rare Blood Cancer
Following its acquisition of ImmunoGen, AbbVie has secured FDA approval for a new cancer therapy for a rare hematologic malignancy.
AstraZeneca's Imfinzi Approved in Combination with BCG for High-Risk Bladder Cancer
The FDA approved Imfinzi in combination with Bacillus Calmette-Guerin (BCG) for adult patients with BCG-naïve, high-risk NMIBC.
Pierre Fabre's Braftovi Combo Receives Positive CHMP Opinion for First-Line mCRC
The EMA's CHMP recommended approval for Braftovi combined with Cetuximab and FOLFOX for the first-line treatment of BRAFV600E-mutated mCRC, based on the Phase 3 BREAKWATER study.
Sun Pharma to Present Positive Long-Term Data for Cosibelimab at ASCO
Pivotal long-term follow-up data shows a complete response rate of nearly 27%, with the median duration of response not yet reached and a favorable safety profile.
📁 All Events (14642 stories)
AbbVie has secured FDA approval for an unnamed cancer asset from ImmunoGen, indicated for rare blood cancer. This marks another regulatory success following AbbVie's acquisition of ImmunoGen, alongside the ongoing commercial growth of the antibody-drug conjugate Elahere.
AbbVie has secured FDA approval for an unnamed cancer asset from ImmunoGen, indicated for rare blood cancer. This marks another regulatory success following AbbVie's acquisition of ImmunoGen, alongside the ongoing commercial growth of the antibody-drug conjugate Elahere.
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
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.
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
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
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.