Pharmaceuticals, Biotechnology and Life Sciences
Kitov Pharmaceuticals Holdings Ltd, a NASDAQ and TASE listed innovative biopharmaceutical company, said Monday that that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application filing fee for Kitov’s patented combination of …
The Food and Drug Administration (FDA) has advised consumers not to purchase or use African Viagra, a product promoted for sexual enhancement.
U.S. Food and Drug Administration (FDA) has granted regular approval to AstraZeneca’s osimertinib (Tagrisso), for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
GlaxoSmithKline’s new CEO Emma Walmsley, who takes over on April 1, has won a short-term reprieve from the threat of generic Advair with a delay in U.S. approval for Mylan’s copy of the blockbuster lung inhaler.
U.S. Food and Drug Administration (FDA) has approved Roche’s subsidiary Genentech’s Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
The U.S. Food and Drug Administration has approved Tesaro’s Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.
EMD Serono, U.S. company focused on specialty care has received U.S. Food and Drug Administration (FDA) approval for its rare skin cancer drug.
The U.S. Food and Drug Administration has approved Newron Pharmaceuticals’s Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa.
Allergan has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLLURETM XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21.
AstraZeneca’s subsidiary ZS Pharma has been developing an oral powder as a treatment for high potassium levels in the blood serum, called hyperkalaemia, for which it got a Complete Response Letter (CRL) from the Food and Drug Administration (FDA).