📁 All Events (14533 stories)
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
Bio-Thera Solutions' golimumab biosimilars, IMMGOLIS™ and IMMGOLIS INTRI™ (golimumab-sldi), received FDA approval as the first biosimilars to Simponi® and Simponi Aria®. Accord BioPharma will commercialize these products in the United States.
Bio-Thera Solutions' golimumab biosimilars, IMMGOLIS™ and IMMGOLIS INTRI™ (golimumab-sldi), received FDA approval as the first biosimilars to Simponi® and Simponi Aria®. Accord BioPharma will commercialize these products in the United States.
The FDA has approved IMMGOLIS (golimumab-sldi) and IMMGOLIS INTRI (golimumab-sldi) as the first biosimilars to Simponi and Simponi Aria. Accord BioPharma will lead the U.S. commercialization of these drugs. IMMGOLIS is approved for the treatment of adults with moderately to severely active rheumatoid arthritis.
The FDA has approved IMMGOLIS (golimumab-sldi) and IMMGOLIS INTRI (golimumab-sldi) as the first biosimilars to Simponi and Simponi Aria. Accord BioPharma will lead the U.S. commercialization of these drugs. IMMGOLIS is approved for the treatment of adults with moderately to severely active rheumatoi
The FDA has approved Enhertu, developed by Daiichi Sankyo and AstraZeneca, for two new indications in HER2-positive early breast cancer.
The FDA has approved Enhertu, developed by Daiichi Sankyo and AstraZeneca, for two new indications in HER2-positive early breast cancer.
Alumis is exploring strategic alternatives for its drug program, a potential rival to Amgen's Tepezza. The company has decided to halt the program and will not pursue the previously envisaged Phase 3 development.
Alumis is exploring strategic alternatives for its drug program, a potential rival to Amgen's Tepezza. The company has decided to halt the program and will not pursue the previously envisaged Phase 3 development.
Aardvark Therapeutics plans to unblind data from its phase 3 Prader-Willi syndrome program. This decision comes after the FDA imposed a full clinical hold on the company's studies.
Aardvark Therapeutics plans to unblind data from its phase 3 Prader-Willi syndrome program. This decision comes after the FDA imposed a full clinical hold on the company's studies.
The FDA approved Tecentriq's label expansion for post-surgical bladder cancer. This approval was granted alongside Natera's Signatera, which will serve as a companion diagnostic.
The FDA approved Tecentriq's label expansion for post-surgical bladder cancer. This approval was granted alongside Natera's Signatera, which will serve as a companion diagnostic.
On May 15, 2026, the FDA approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) by Genentech, Inc. These drugs are approved as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA.
On May 15, 2026, the FDA approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) by Genentech, Inc. These drugs are approved as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA.
The FDA approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi) as the first interchangeable biosimilars to Simponi and Simponi Aria (golimumab), respectively. These biosimilars are indicated for the treatment of rheumatoid arthritis and ulcerative colitis.
The FDA approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi) as the first interchangeable biosimilars to Simponi and Simponi Aria (golimumab), respectively. These biosimilars are indicated for the treatment of rheumatoid arthritis and ulcerative colitis.