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Browsing Tag

fda

177 posts
MMedication
FDA voucher program has led to political interference in drug reviews, staffers say
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FDA voucher program has led to political interference in drug reviews, staffers say

  • December 19, 2025
WASHINGTON — A new program intended to fast-track drug reviews at the Food and Drug Administration is quickly…
MMedication
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Female libido pill gets expanded approval for menopause by FDA

  • December 17, 2025
U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now…
MMedication
Does Novo Nordisk's (CPSE:NOVO B) Alzheimer’s Setback Challenge Its Long-Term Diversification Ambitions?
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Will FDA Approval of an In‑House Teriparatide Pen Reshape Amphastar Pharmaceuticals’ (AMPH) Narrative?

  • December 17, 2025
In December 2025, Amphastar Pharmaceuticals announced that the FDA approved its abbreviated new drug application for a teriparatide…
MMedication
ACCESS Newswire
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Amphastar Announces FDA Approval for Teriparatide Injection

  • December 15, 2025
RANCHO CUCAMONGA, CA / ACCESS Newswire / December 15, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the…
MMedication
Regulatory reform can unlock access to biosimilars
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Regulatory reform can unlock access to biosimilars

  • December 5, 2025
Every day, I think about the patients waiting for medicines that could change, or even save, their lives.…
HHealthcare
Otsuka’s kidney therapy gets accelerated FDA approval
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Otsuka’s kidney therapy gets accelerated FDA approval

  • December 2, 2025
Voyxact gets accelerated approval, offering investors a new entrant in the high-value kidney disease market. The Food and…
BBusiness
Blaming some child deaths on covid shots, FDA vows stricter vaccine rules
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Blaming some child deaths on covid shots, FDA vows stricter vaccine rules

  • November 30, 2025
Dan Diamond and Rachel Roubein Washington Post· 30 Nov, 2025 07:01 PM3 mins to read Subscribe to listenAccess…
MMedication
Walgreens recalls nasal spray over possible contamination
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Walgreens recalls nasal spray over possible contamination

  • November 28, 2025
(CNN) – Walgreens is recalling more than 41,000 bottles of nasal spray because they may be contaminated with…
HHealthcare
Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg
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Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg

  • November 26, 2025
If approved, investigational semaglutide 7.2 mg injection would offer the optionality of a higher dose for greater weight…
MMedication
FDA reviewers didn't get to vote on first priority voucher drug
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FDA reviewers didn’t get to vote on first priority voucher drug

  • November 21, 2025
WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one-…
MMedication
ADHD medication recalled nationwide because users aren’t getting the full effect
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ADHD medication recalled nationwide because users aren’t getting the full effect

  • November 14, 2025
(Gray News) – A popular ADHD medication is being recalled nationwide because its users won’t be able to…
MMedication
New FDA-approved eye drop aims to help adults with age-related vision issues
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New FDA-approved eye drop aims to help adults with age-related vision issues

  • November 13, 2025
There is a new FDA-approved eye drop on the market called Vizz. This once-daily, prescription eye drop is…
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