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President Trump signed Congress’ combined appropriations and COVID-19 relief package late on Sunday, averting a looming federal government shutdown. Read More
The FDA rapped California-based drug manufacturer Sky Systems in a Form 483 with a dozen observations after an inspection revealed the firm lacked a quality control unit. Read More
By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the FDA said in a final guidance issued last week. Read More
In 2020, messenger RNA (mRNA), the technology behind Pfizer’s and Moderna’s COVID-19 vaccine, practically became a household word. Now the gate is open for more mRNA vaccines to flood the space. Read More
Swedish drugmaker Vicore Pharma has reported positive results from a phase 2 study evaluating its oral therapy for treating respiratory infection in hospitalized COVID-19 patients. Read More
Merck has signed a contract to supply up to 100,000 doses of its experimental COVID-19 treatment, MK-7110, to the U.S. government for $356 million, provided the investigational biologic earns the FDA’s approval or Emergency Use Authorization. Read More
The U.S. and Pfizer have agreed to another vaccine supply deal that will net the government an additional 100 million doses of Pfizer/BioNTech’s coronavirus vaccine in summer 2021. Read More