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April 23, 2020
The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.
April 22, 2020
The company is recalling the product because of out-of-specification results for high molecular weight polymers.
The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.
With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.
April 17, 2020
The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.
April 16, 2020
The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.
Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.
April 15, 2020
The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.
April 08, 2020
EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.
The agency sent a warning letter to Genesis II Church for marketing fraudulent chlorine dioxide products the company claims treats and prevents COVID-19.