March 31, 2017
FDA warnes African Viagra’s possible harmful ingredient
The Food and Drug Administration (FDA) has advised consumers not to purchase or use African Viagra, a product promoted for sexual enhancement.
Pharmaceuticals, Biotechnology and Life Sciences
Tag: FDA
March 31, 2017
AstraZeneca wins FDA’s full approval for its lung cancer drug
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).
March 30, 2017
GSK’s new CEO gets short-term win from generic Advair delay
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.
March 29, 2017
Roche’s subsidiary Genentech wins FDA approval for MS and PPMS
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).
March 28, 2017
FDA OK’s Tesaro’s ovarian cancer drug
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.
March 24, 2017
FDA approves EMD Serono’s rare skin cancer drug
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.
March 22, 2017
FDA OK’s Parkinson’s disease 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.
March 21, 2017
FDA OK’s Allergan’s beauty drug
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.
March 17, 2017
AstraZeneca to resolve certain matters related to development of hyperkalameia powder
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).
March 16, 2017
FDA fees for product review would more than double under Trump budget
The cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration’s proposed 2018 budget.