The FDA issued yesterday (8/5) Emergency Use Authorization for Vela Diagnostics for the manual version of their Covid PCR test. The manual version of the test enables flexible sample processing, facilitating widespread use of the test throughout the United States. Sam...
The FDA approved today (7/31) RedHill Biopharma’s investigational new drug (IND) application for phase 3 of RHB-204 for pulmonary NTM infection in adults. NTM (nontuberculous mycobacteria) is a chronic lung disease caused by environmental bacteria typically near...
The US House of Representatives approved of a $3.2 billion budget for the FDA for the 2021 fiscal year, a $40.8 million increase from the 2020 fiscal year. The additional funding is meant to support new initiatives for greater collaboration across departments within...
The US government will pay American pharmaceutical leader Pfizer and German biotech BioNTech $1.95 billion USD to buy enough COVID-19 vaccines for approximately 50 million people. Pfizer and BioNTech will not receive payment until their...
The European Commission (EC) has granted approval for Novartis’ Enzair Breezhaler, a medicine for uncontrolled asthma. The drug therapy is utilized as a maintenance treatment for adults with asthma. “Novartis is working to reimagine medicine for people with...
The US House Committee on Appropriation approved a $3.212 billion budget for the 2021 fiscal year. Part of the funding bill also gives the Food and Drug Administration authority to recall unsafe prescription and over-the-counter drugs. The proposed budget also...
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