Venclexta (venetoclax) has received FDA approval in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.
Tagrisso receives FDA Priority Review for adjuvant treatment of early-stage EGFR-mutated lung cancer
Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application and has also been granted Priority Review by FDA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.
Keytruda (pembrolizumab) has received an expanded label use from FDA as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.
The United Kingdom plans to join two international initiatives that will allow pharmaceutical companies to submit medicines to be reviewed by several countries at the same time, pooling resources and allowing patients to benefit from earlier access.
MD Anderson Cancer Center and Allogene Therapeutics Inc. have entered into a five-year collaboration agreement for the preclinical and clinical investigation of AlloCAR T candidates across Allogene's portfolio of hematologic and solid tumors.
Opdivo (nivolumab) in combination with Yervoy (ipilimumab) received FDA approval for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
Regeneron has submitted a request to FDA for Emergency Use Authorization approval for the
FDA has issued draft guidance encouraging the inclusion of premenopausal women in breast cancer clinical trials that investigate the efficacy of hormonal drug and biological products.
FDA has granted Rare Pediatric Disease Designation for IVT-8086 for the treatment of Osteosarcoma.
Celyad Oncology SA, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell therapies for cancer, has entered into a clinical trial collaboration with Merck & Co., Inc., through a subsidiary.
