Approvals
It’s a busy week for GlaxoSmithKline, although much of it is related to the upcoming demerger of its Consumer Healthcare business. Here’s a look.
The company said its Allergan eye drops met both its primary and key secondary endpoints, with patients reporting near and intermediate improvements in vision.
In a filing with the U.S. Securities and Exchange Commission earlier this month, Rosenbaum and his investment group nominated five directors to elect the CytoDyn board.
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns.
The FDA has now approved AstraZeneca’s convenient once-a-week glucose lowering drug for 10 to 17-year-olds with type 2 diabetes.
The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.
The FDA placed a clinical hold on Magenta’s clinical program for acute myeloid leukemia and myelodysplastic syndrome, which made its shares drop nearly 7% this morning.
Genentech announced that the FDA has green-lit the Venclexta classification and azicitidine combination as a Breakthrough Therapy Drug.
Pfizer has voluntarily recalled two lots of Chantix 0.5 mg tablets, two lots of Chantix 1 mg tablets, and eight lots of a Chantix kit consisting of 0.5mg/1 mg tablets.
PRESS RELEASES