Tag: Drug Approvals
Precedent Needed for FDA Approval Decisions When Evidence Lacking
In seven of 22 cases, approval used new interpretations of original evidence and did not require new evidence
Xywav Gets FDA Approval to Treat Rare Sleep Disorder
First drug to be approved by the agency for idiopathic hypersomnia
Enzyme Replacement Therapy Approved for Late-Onset Pompe Disease
Patients taking Nexviazyme saw improvements in respiratory function and walking distance measures
REGEN-COV Authorized for Postexposure Prophylaxis in High-Risk Individuals
Emergency use authorization indicated for those who have been exposed to SARS-CoV-2 and have an immunocompromising condition
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
