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Xeljanz, a Janus kinase inhibitor, is FDA-approved for several indications, including for patients with moderate-to-severe active ulcerative colitis. Read More
Astellas Pharma and two other plaintiffs have filed a patent infringement lawsuit in an effort to stop Zydus Pharmaceuticals from marketing a generic version of the prostate cancer drug Xtandi (enzalutamide). Read More
Catalyst Pharmaceuticals has settled with Jacobus Pharmaceutical over claims that Jacobus’ Lambert-Eaton myasthenic syndrome (LEMS) drug Ruzurgi (amifampridine) infringed on its patent rights for Firdapse (amifampridine). Read More
The FDA would be compelled to finalize a 15-year old proposed rule requiring drugmakers to cease using distracting images and sounds in TV ads under a new bill introduced in the House. Read More
Five months into his tenure as FDA commissioner, Robert Califf warned that the agency’s ability to review medical products would be drastically curtailed if Congress doesn’t pass a user fee reauthorization package by August. Read More
Drugs containing nomegestrol or chlormadinone are typically used for gynecological and menstrual disorders, hormone replacement therapy and, at lower doses, as hormonal contraceptives. Read More
Zynlonta was granted FDA accelerated approval in April 2021 as a single-agent intravenous treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. Read More
The FDA has received heavy pushback from industry groups on its revised plan to collect quality metrics data from manufacturers, according to public comments on two volunteer pilots, the Site Visit and Quality Metrics (QM) Feedback programs. Read More