Fda

The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development

Few vaccine developers were expected to have definitive trial results before the US presidential electionThe trials are designed for people to receive their second shot either 3 or 4 weeks after the first

For a vaccine to be widely available in coming months, a long list of exceptionally difficult goals have to be met

The British drugmaker and its partner, the University of Oxford, put research into the shot on hold last week after the volunteer suffered neurological symptoms

FDA leaders are insulating the agency’s vaccine reviewers from outside political pressure by sticking by June guidelines that set the standard for what it will take for a vaccine to pass through the agency

US FDA to review GlaxoSmithKline's experimental treatment for multiple myeloma, a common form of blood cancer, evaluate how belantamab mafodotin can cause keratopathy, a side-effect where deposits gather on the cornea of the eye

Due to lack of substantial proof and process, U.S. FDA has denied approval to multiple cancer drugs of several companies

Several southern and western states are seeing surging new case numbers, prompting some to put reopening plans on holdNIAID director Fauci says he’s ‘aspirationally hopeful’ that a vaccine for Covid-19 will be ready in early 2021, though he cautions that there’s no guarantee that a safe vaccine will be developed

Food and Drug Administration announces emergency authorization for antigen tests developed by Quidel Corporation of San DiegoThe test can rapidly detect fragments of virus proteins in samples collected from swabs swiped inside the nasal cavity

The US FDA had inspected the pharmaceutical company’s unit during 4-13 NovemberThe company had received Form 483 with 14 observations