Pharmaceutical Technology

FEBRUARY 23, 2023

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

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PharmaVoice

JUNE 25, 2025

Clene stated in December it was working with the FDA on a path toward accelerated approval , with a plan to leverage additional analyses of a protein that may signal neuronal damage and has potential as an ALS biomarker. Amylyx is currently in phase 1 testing after dosing the first trial participants in April 2025.

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Viseven

AUGUST 15, 2024

For instance, the FDA’s requirement for Patient Perspectives in drug reviews has made patient engagement crucial for approvals and reimbursements. Engagement can lead to improvements in drug delivery methods, packaging designs, and support services that enhance the overall patient experience.

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Pharmacy Times

JUNE 23, 2025

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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Pharmaceutical Technology

JULY 2, 2025

The US Food and Drug Administration (FDA) approved Yeztugo last month , bringing a more convenient PrEP option for adults and adolescents at risk of HIV exposure. The Elton John AIDS Foundation said it was “pleased to hear about the FDA approval of lenacapavir as a new and extremely effective prevention technology for HIV transmission”.

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Pharmaceutical Technology

JULY 2, 2025

Ogsiveo (nirogacestat) is approved by the Food and Drug Administration (FDA) for adults with progressing desmoid tumours requiring systemic treatment. How will RFK Jr’s American dream for vaccines play out? The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) also recommended its approval in June 2025.

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Pharmacy Times

JUNE 11, 2025

FDA approves tablet formulation of BeOne's BRUKINSA for all approved indications. Package insert. Coverage of this story is ongoing. 1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. 1 REFERENCES 1.

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Pharmaceutical Technology

JULY 2, 2025

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.

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Pharmaceutical Technology

JULY 2, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 2, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 2, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 2, 2025

For gene therapy in the US, there are eight FDA-approved oncologic treatments, with prices ranging from $65,000 to $475,000. To learn more about Oximio’s services in cell and gene logistics, register for the forthcoming webinar below. How will RFK Jr’s American dream for vaccines play out? However, costs can soar even higher.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry.” Draft Guidance for Industry.

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The FDA Law Blog

NOVEMBER 22, 2022

Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. All records required under the final rule must be made available to FDA within 24 hours after a request is made. coli contamination.

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PharmaVoice

JUNE 30, 2025

Published June 30, 2025 Amy Baxter Staff Reporter post share post print email license FDA Commissioner Dr. Marty Makary speaks during a news conference at HHS on April 22, 2025 in Washington, DC. But Commissioner Dr. Marty Makary has vowed to keep the review wheels churning, and the FDA recently launched its AI tool , Elsa, to help.

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ISPE

JANUARY 10, 2023

The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review. US Food and Drug Administration webinar. 3 Ramanadham, M. Published 3 September 2021.

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Pharmacy Times

JUNE 5, 2025

Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. Pharmacists must adapt to new tools, ensuring safe medication distribution through improved literacy and teamwork. 1-3 Detect-A-Dose Lid Label Covers.

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PharmaVoice

JUNE 18, 2025

billion in sales that year, despite the FDA finding the ads “made unsupported and misleading claims of effectiveness and minimized its safety risks.” But a ban enacted through legislation is more likely to hold up in court than a policy change by the FDA. The bill will likely face legal challenges from the pharma industry.

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