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The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.
MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.
What are the regulatory constructs that the FDA puts out in front of you to get there? And then how do you develop documents to basically get approval from the FDA to study your drug in humans? There’s a lot of other aspects that go along with it, but at a high level that’s roughly what that was.
YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
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Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
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FDA guidance documents illustrate labeling salt drugs and associated active moieties. The secondary label will specify the Drug ZA-ion amount per capsule and the equivalent Drug Z-salt amount consistent with FDA labeling guidance. Additional mole calculations are needed only for drug-name labeling per FDA guidance ( Figure 5b above).
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Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. Concerningly, preventable adverse events due to medication errors cause an estimated 44,000 to 98,000 hospital deaths annually, more than the number attributed to motor vehicle accidents.
How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.
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Numerous institutions—such as the NIH, CDC, FDA, and others—are experiencing significant disruptions, compromising efforts across multiple disease states. In June 2025, the White House submitted a formal rescissions package to Congress that proposed eliminating billions in foreign aid funding—including over $8 billion allocated to USAID.
Image Credit: REDPIXEL - stock.adobe.com Thimerosal is a mercury-containing compound that has been widely used as a preservative in some biological and drug products, such as promoting the safe use of multidose vials and packaging of vaccines. It is often thought to be used in some seasonal and pandemic influenza vaccines. 4 REFERENCES 1.
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Fentanyl may also be prescribed off-label, meaning for a purpose other than what the Food and Drug Administration (FDA) approved it for. FDA, 2024) Brand names of fentanyl include Sublimaze, Actiq, Fentora, and Duragesic. Pharmaceutical fentanyl typically comes with official labeled packaging and a medication guide. As of Sept.
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US market provides uptake hint The US Food and Drug Administration (FDA) approved Alyftrek in December 2024 , providing a window into market dynamics for the drug. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug applications submitted between 2020 and 2024. How will RFK Jr’s American dream for vaccines play out? Credit: Tada Images/Shutterstock.
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How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
Find out more The transaction will enhance Merck’s cardio-pulmonary pipeline and portfolio with the addition of Ohtuvayre (ensifentrine), an FDA-approved treatment for chronic obstructive pulmonary disease (COPD) in adults. How will RFK Jr’s American dream for vaccines play out? Credit: Merck & Co.,
How will RFK Jr’s American dream for vaccines play out? of equity shares from JB employees at the same price per share as offered to KKR. of equity shares from JB employees at the same price per share as offered to KKR. Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations. By GlobalData Learn more about Strategic Intelligence The company then plans to expand into a Phase Ib proof-of-concept trial in patients with KCNT1-related epilepsy in early 2026.
Manasi Vaidya June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook BIO President John Crowley [L] speaking to US FDA Commissioner Dr Marty Makary [R] at the BIO International Convention in Boston. Data Insights The gold standard of business intelligence. Give your business an edge with our leading industry insights.
The US Food and Drug Administration (FDA) has approved Takeda’s new immunoglobulin (IG) therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat primary immunodeficiency (PI) in individuals aged two years and above. Credit: HenadziPechan/Shutterstock. Give your business an edge with our leading industry insights.
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How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
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