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The FDA has announced that it is requiring an update to the Boxed Warning for benzodiazepines to include the risks of abuse, physical dependence and withdrawal reactions associated with their use. Read More
Relief Therapeutics and NeuroRx have applied to the FDA for an Emergency Use Authorization (EUA) for RLF-100 (aviptadil) for the treatment of critical COVID-19 patients with respiratory failure. Read More
In a stunning departure from how FDA guidances are issued by the agency, President Donald Trump said Wednesday evening that he might move to reject a guidance that is expected to impose stricter thresholds for any COVID-19 vaccine Emergency Use Authorizations (EUAs). Read More
The House voted to pass a short-term funding measure to keep the government running through Dec. 11 at fiscal 2020 funding levels for fiscal 2021, which begins Oct. 1. Read More
In a Senate hearing yesterday, Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said that “some time by November or December we will know” which of the three COVID-19 vaccine candidates now in late-stage trials — soon to be joined by a fourth — are safe and effective. Read More
Johnson and Johnson (J&J) yesterday became the fourth drugmaker to begin a large-scale phase 3 trial of a COVID-19 vaccine candidate — and it will be the largest late-stage trial of a COVID-19 vaccine to date. Read More
In a proposed rule released yesterday, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
Chinese drugmakers Sinovac Biotech and CanSino Biologics yesterday began separate late-stage trials of their COVID-19 vaccines in Turkey and Pakistan. Read More
New York biotech Codagenix announced Tuesday that the Serum Institute of India has begun manufacturing its intranasal COVID-19 vaccine candidate, CDX-005. Read More