NIH and FDA envision transforming the way clinical trials are done across the biomedical research enterprise.
FDA approved Jaypirca (pirtobrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
FDA granted Fast Track Designation for Alpha1H for the treatment of non-muscle invasive bladder cancer. Alpha1H is sponsored by Hamlet BioPharma AB.
FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies.
FDA approved Xtandi (enzalutamide) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory follicular lymphoma.
Invoking the Defense Production Act, President Joe Biden has ordered federal agencies and artificial intelligence companies to create safeguards and standards for the technology that has the capacity to uplift humankind as much as it can wreak unimaginable harm.
As a data scientist and software engineer, Razik Yousfi builds artificial intelligence models in health care. He started doing this 15 years ago, long before advanced chatbots catapulted AI into the layman’s consciousness.
The FDA Oncologic Drugs Advisory Committee earlier this week was asked to review two of the slowest-moving confirmatory trials.
FDA approved Keytruda (pembrolizumab) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
