Food and Drug Administration (FDA)
NEWS
The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.
The FDA placed a clinical hold on Magenta’s clinical program for acute myeloid leukemia and myelodysplastic syndrome, which made its shares drop nearly 7% this morning.
Genentech announced that the FDA has green-lit the Venclexta classification and azicitidine combination as a Breakthrough Therapy Drug.
It will immediately begin to sell Bylvay to treat patients impacted by PFIC, a rare cholestatic liver disease that often leads to cirrhosis and liver failure within the first ten years of life.
The company also reported on its COVID-19 vaccine production with CureVac, a drug it is abandoning, and a few specific drug updates.
The company’s technology is designed to attach any off-the-shelf antibody with any payload without the need for modification.
Pfizer has voluntarily recalled two lots of Chantix 0.5 mg tablets, two lots of Chantix 1 mg tablets, and eight lots of a Chantix kit consisting of 0.5mg/1 mg tablets.
The lawsuit alleges that Ocugen made “materially false and misleading statements” about its operations and compliance policies.
The FDA said it found an issue with the “size of the treatment effect and clinical relevance” of Ardelyx’s new drug tenapanor without providing additional details.
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