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The FDA granted AstraZeneca a Priority Review for its blockbuster oncology drug, Imfinzi (durvalumab), combined with chemotherapy, for treatment of patients with locally advanced or metastatic biliary tract cancer (BTC), a rare cancer affecting the bile ducts and gallbladder. Read More
Novartis has paused production of two radioligand cancer therapies manufactured at its Ivrea, Italy, and Millburn, N.J., plants after potential quality issues surfaced. Read More
After resolving drug quality issues, Marinus Pharmaceuticals has resumed screening and recruitment for a phase 3 trial of its investigational drug ganaxolone in refractory status epilepticus (RSE). Read More
Almost 11 years after it granted Accelerated Approval, the FDA is withdrawing approval for Celgene’s (now Bristol Myers Squibb’s) peripheral T-cell lymphoma (PTCL) indication for Istodax (romidepsin) after the cancer drug didn’t achieve the primary endpoint in its confirmatory trial. Read More
AstraZeneca’s complement-5 inhibitor Ultomiris (ravulizumab-cwvz) has shown benefit in people living with a rare degenerative neuromuscular disorder called anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Read More
The industry is speaking out about worries that must-pass legislation that reauthorizes FDA’s user fee programs might get bogged down with lawmakers’ projects and other effluvium that could alter the agreements FDA and industry have negotiated together. Read More
With the change to regular approval, Enhertu can now be used in earlier lines of treatment in patients with HER2-positive metastatic breast cancer. Read More
Citing the risk of rare blood clots, the FDA announced late yesterday that it is limiting the Emergency Use Authorization (EUA) for the Johnson & Johnson/Janssen COVID-19 vaccine to certain individuals. Read More
The FDA has issued a warning letter to the Age Management Institute (AMI) in Santa Barbara, Calif., for violations that caused its compounded drugs to be adulterated. Read More