Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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Pharmaceutical Technology

JUNE 13, 2025

June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The approval marks AbbVie’s therapy as the first and only DAA treatment approved for this patient group. Credit: © AbbVie Inc. All rights reserved. ” Mavyret had also secured a breakthrough therapy designation from the US regulator for acute HCV.

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LifeProNow

JANUARY 18, 2025

January 15, 2025 : “Johnson & Johnsonannounced it has initiated the submission of an original New Drug Application with the U.S. It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes and without the need for anesthesia.

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Pharmaceutical Technology

JUNE 16, 2025

GlobalData Healthcare June 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Surovatamig’s global sales are projected to reach $138 million by 2031. GlobalData Healthcare June 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Surovatamig’s global sales are projected to reach $138 million by 2031.

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PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). Figure 3: Fluorescence profile of released N-glycans from a monoclonal antibody following fluorescent labelling and liquid chromatography-mass spectrometry (LC-MS) analysis.

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The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items.

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Pharmacy Times

JUNE 11, 2025

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. Zanubrutinib tablets are set to replace capsules beginning in October 2025, according to the news release. Released June 11, 2025. Package insert.

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PharmaTech

JUNE 12, 2025

Image Credit: © Tada Images - stock.adobe.com In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back to 2020 (1). American Behavioral Research Institute Boca Raton, Fla. –

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Pharmaceutical Technology

JUNE 16, 2025

Robert Barrie June 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Elevidys is the only gene therapy approved in US for DMD. By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Dragon Claws via Shutterstock.

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FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). non-standardized foods), their labeling must bear the common or usual name of the food, if such a name exists.

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PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

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Pharmaceutical Technology

JUNE 13, 2025

Robert Barrie June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook mRESVIA is the second approved product in the US for Moderna, along with its Covid-19 vaccine Spikevax. This usually begins around November and peaks in the mid-Winter months. Give your business an edge with our leading industry insights.

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FDA Law Blog: Biosimilars

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging. By Charles D. Snow & Deborah L.

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Pharmaceutical Technology

JUNE 6, 2025

Robert Barrie June 6, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook NHS England estimates that nearly 2.5 Figures published in May 2025 by NHS England estimated there were nearly 2.5 Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults.

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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. 1-3 Detect-A-Dose Lid Label Covers. 1-3 Detect-A-Dose Lid Label Covers. Image Credit: © Medi-Dose, Inc.

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