FDA has received reports of immune effector cell-associated enterocolitis in patients who received treatment with Carvykti.
Tempus AI was selected by the Advanced Research Projects Agency for Health to provide testing and contract research organization services in support of the agency’s Advanced Analysis for Precision Cancer Therapy program.
Algen Biotechnologies and AstraZeneca are entering into a multi-target research collaboration to advance AI-powered drug discovery in immunology.
FDA approved cemiplimab-rwlc (Libtayo) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
FDA has granted a approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance treatment for adults with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
FDA has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.
FDA has granted Fast Track designation to UB-VV111 for the treatment of relapsed/refractory large B-cell lymphoma following two or more lines of prior therapy and relapsed/refractory chronic lymphocytic leukemia following two or more lines of prior therapy.
FDA has published a new guidance for the development of non-opioid pain treatments in the Federal Register.
FDA approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Sept. 19 for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted two positive opinions for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.
