Tag: Drug Approvals
Full Approval of Pfizer COVID-19 Vaccine Could Come in September
FDA said in a statement that its leaders recognized that full approval might counter vaccine hesitancy
Report Questions Benefit of FDA Accelerated Approval Pathway
112 of the 253 authorized drugs have not been confirmed as clinically effective; 24 of these have been on market more than five years
FDA Approves First Biosimilar Insulin Product
Semglee (insulin glargine-yfgn) is biosimilar to and interchangeable with Lantus (insulin glargine), provides cost-effective option
FDA Head Asks for Investigation Into Alzheimer Disease Drug Approval
Request follows reports that Biogen and the FDA held off-the-books meetings before the drug's approval that may have violated FDA protocol
House Committees to Investigate New Alzheimer Disease Drug Approval
FDA approved Aduhelm earlier this month, despite advisory committee's conclusion that there was not enough evidence to support its effectiveness
FDA OKs First Oral Blood Thinning Medication for Children
Pradaxa approved for children ages 3 months to 12 years with VTE directly after treatment with injectable blood thinner for at least five days
Three FDA Advisers Quit Over Agency Approval of Aduhelm
Several experts have said the available evidence about Aduhelm raises significant doubts about its effectiveness
FDA Approves Aduhelm for Alzheimer Disease
Agency says it has granted approval on the condition that drug maker Biogen conduct a new clinical trial
Farxiga Approved to Reduce Risk for CKD Progression
SGLT2 inhibitor approved for patients with CKD to prevent kidney function decline, kidney failure, CV death, hospitalization for heart failure
FDA Approves Higher-Dose Naloxone Hydrochloride Nasal Spray
8-mg dose of naloxone hydrochloride nasal spray now approved with 2-mg and 4-mg doses
