Clinical research
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended 14-1 that the two companies conduct a trial applicable to the U.S. population.
Shares of Alnylam Pharmaceuticals are sliding in morning trading despite the news that the company’s revenues grew by 83% in 2021 compared to the previous year.
Ardelyx has reported in a regulatory filing that the FDA sent an Appeal Denied Letter for its drug tenapanor, a therapeutic intended for chronic kidney disease.
The EUA request is based on the Phase II study that showed treatment with ensovibep reduced the viral load from the SARS-CoV-2 virus within eight days of use compared to placebo.
Merck has announced positive results from its Phase III KEYNOTE-522 study on the use of KEYTRUDA alongside chemotherapy in high-risk early-stage triple-negative breast cancer.
REGENXBIO presented results from its ongoing Phase I/II trial of RGX-111, an investigational one-time gene therapy for people with Mucopolysaccharidosis Type I (MPS I).
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
enGene announced positive results from its LEGEND Phase I/II clinical trial for treating high-grade NMIBC in patients with carcinoma in situ that are unresponsive to BCG treatment.
Statistically significant weight loss and liver fat reduction were seen across all dosage groups—with no changes to diet or exercise.
Endevica Bio isn’t trying to cure cancer. Instead, it is focused on improving cancer patients’ quality of life and preventing deaths.
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