FDA Approval Licensing Pharmacy Regulation 
Pharmaceutical Technology
OCTOBER 31, 2022
The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.
XTalks
JULY 19, 2024
Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The report also shows a rapid rise in compounding pharmacies.
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Pharmacy Checkers
JANUARY 10, 2020
This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. pharmacies. and arguably just as safe. Let’s call him John.
FDA Law Blog
OCTOBER 12, 2022
As background, naloxone hydrochloride (“naloxone”) is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdoses and is available in three FDA-approved forms (injectable, auto-injector, and nasal spray). plies for administration (e.g.,
The Pharma Data
MAY 13, 2021
‘More Amazon and less pharmacy’: one exec on the company’s strategy for prescription drugs ( STAT ). Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). ICER, Accelerated Approval And The Payer Voice At The US FDA ( Pink Sheet ). Pharma & Biotech.
XTalks
APRIL 24, 2023
The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.
Pharmacy Checkers
OCTOBER 2, 2020
Unlike wholesale importation, Section 804 does not legalize personal importation from Canada or other countries, but it does permit it through enforcement discretion, regulation or waiver. They do so by buying directly from pharmacies in other countries. Personal importation is directly importing from a pharmacy in Canada.
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