⚡ Top Events Today
AstraZeneca and Daiichi Sankyo Secure FDA Approval for Datroway in Metastatic TNBC
The FDA has approved Datroway for adult patients with unresectable or metastatic TNBC.
FDA Approves First-Ever Treatment for Chronic Hepatitis Delta Virus (HDV)
The FDA approved Hepcludex injection, the first treatment for chronic HDV in adults without cirrhosis or with compensated cirrhosis.
Pierre Fabre's Braftovi Combination Recommended for First-Line mCRC Approval in EU
The EMA's CHMP issued a positive opinion for Braftovi in combination with cetuximab and FOLFOX for first-line treatment, based on the Phase 3 BREAKWATER study.
Sun Pharma Presents Strong Long-Term Phase 3 Data for UNLOXCYT in Skin Cancer at ASCO
Long-term follow-up data showed a complete response rate of nearly 27%, with median duration of response not yet reached and a favorable safety profile.
Merck & Kelun-Biotech Report Positive Results from Three Phase 3 Trials for ADC Candidate
The partnered ADC, sac-TMT, met its primary endpoints in three separate Phase 3 clinical trials.
📁 All Events (14588 stories)
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.
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.