The Food and Drug Administration (FDA) asked for rare disease stakeholders, including individuals and families affected by rare disease(s), pharmaceutical companies, trade associations, and other federal agencies and regulators, to weigh in on a proposed clinical...
Vladimir Putin announced on yesterday (8/11) of Russia’s approval for COVID-19 vaccine, “Sputnik V”. The approval comes before the vaccine has completed its final stages in the clinical trials, causing worry from both inside and outside the country. The first round of...
The US Federal Drug Administration (FDA) with the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) has provided guidance today (8/10) for drug-drug interaction studies of therapeutic proteins. The guidance...
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for Covid. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send almost the entirety...
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...
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