pharmaphorum

AUGUST 24, 2022

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The post Amgen’s Soliris biosimilar clears phase 3, but won’t launch until 2025 appeared first on.

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The FDA Law Blog

JANUARY 5, 2025

Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. By Deborah L. 105288 (Dec.

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STAT

SEPTEMBER 13, 2023

In connection with the move away from prescription sales, Akili will reduce its workforce by 40%, which the company projects will extend its runway into the second half of 2025. Akili went public last year and though its prescription sales were slowly increasing, the company’s costs far outstripped its revenues.

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Pharmaceutical Technology

JUNE 18, 2025

June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The company is studying the therapy in the global Phase IIb PRIZM trial. June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The company is studying the therapy in the global Phase IIb PRIZM trial. Credit: Volha_R/Shutterstock.

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Pharmaceutical Technology

NOVEMBER 15, 2024

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

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The Checkup by Singlecare

JUNE 5, 2025

Because of those effects, Mounjaro is sometimes prescribed off-label for weight loss. Aetna isn’t likely to cover Mounjaro for weight loss, especially since the active ingredient in Mounjaro is also available under the name Zepbound , which is FDA approved for weight loss, unlike Mounjaro. Does Aetna cover tirzepatide?

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pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. Dupixent’s label currently calls for dosing every two weeks for all patients. Leo now says it will start rolling the new product out in February.

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The FDA Law Blog

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Tobolowsky & Michelle L. Butler & Deborah L.

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European Pharmaceutical Review

JUNE 12, 2025

Regulatory bodies like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are emphasising the importance of data quality for AI applications in healthcare. Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models. cited 2025Feb].

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European Pharmaceutical Review

MAY 30, 2025

These results are from the Phase II FENopta open-label extension (OLE) study of oral fenebrutinib. Notably, there was no US Food and Drug Administration (FDA)-approved treatments for primary progressive multiple sclerosis (PPMS) until the agency approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) in September 2024, Roche explained.

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Labelling FDA 59

The FDA Law Blog

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).

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pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

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pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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Pharmaceutical Technology

JUNE 7, 2023

Mounjaro’s approval for obesity, particularly in the US and EU markets, means the drug is entering a significantly large market where it will have direct competition from Novo Nordisk’s Wegovy (semaglutide), which is currently the leading glucagon-like peptide-1 (GLP-1) therapy approved for obesity by both the FDA and EMA.

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The FDA Law Blog

OCTOBER 24, 2022

355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

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Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). 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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pharmaphorum

NOVEMBER 30, 2021

The FDA has kicked off its review of Bristol-Myers Squibb’s psoriasis therapy deucravacitinib, setting an action date of 1 September next year, as the EU and Japanese regulators also start their appraisals of the drug. The post FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib appeared first on.

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The Checkup by Singlecare

MARCH 31, 2025

Ozempic is the brand name for semaglutide, which is a medication thats FDA approved to treat high blood sugar in people with Type 2 diabetes. It is also often prescribed off-label as a weight loss medication, even in patients with normal blood sugars.

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The Checkup by Singlecare

JULY 2, 2024

Mounjaro is a popular brand-name medication approved by the Food and Drug Administration (FDA) to improve blood sugar control in people with Type 2 diabetes, along with diet and exercise. One common side effect of Mounjaro is weight loss, which is why it may sometimes be prescribed off-label (for a non-FDA-approved use) for that purpose.

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pharmaphorum

SEPTEMBER 11, 2022

The US FDA has cleared the first-in-class tyrosine kinase 2 (Tyk2) inhibitor as Sotyktu , and BMS says it now plans to launch the new drug later this month, aiming to mount a challenge to Amgen’s $2.3 billion oral psoriasis therapy Otezla (apremilast).

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The FDA Law Blog

JULY 6, 2023

Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023. In fact, the priority designation for the final rule is labeled as “economically significant.”

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The FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR. 860.230.

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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pharmaphorum

AUGUST 9, 2022

Tagrisso meanwhile has been FDA-approved as a second-line treatment for EGFR T790M mutation-positive NSCLC since 2015, with its label extended since then to include first-line and adjuvant treatment. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

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The Checkup by Singlecare

OCTOBER 9, 2024

While Lumigan is a 0.01% solution of bimatoprost and no generic product is manufactured at this concentration, patents on Lumigan expire in 2025 and 2027, so there may be a generic option approved by the Food and Drug Administration (FDA) thereafter. Generic bimatoprost drops are available at a 0.03% concentration currently.

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Pharmacy Times

JUNE 11, 2025

The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.

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OctariusRx

MAY 27, 2025

Our 2025 Medication Calculations quiz is now available. Food and Drug Administration (FDA) receives more than 100,000 reports associated with a suspected medication error. Read the medication label carefully: This is a critically important step and one that often leads to errors and potential patient harm. Each year, the U.S.

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Pharmacy Times

JUNE 9, 2025

The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. 43, 2025 (suppl 17; abstr LBA1000). Updated March 13, 2025.

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PharmTech

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. References Mordor Intelligence.

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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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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. 1 REFERENCES 1.

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Pharmacy Times

JUNE 16, 2025

Nemolizumab targets IL-31 receptor alpha, inhibiting itch and inflammation, and is FDA-approved for use with topical therapies in patients 12 and older. 1 The findings were presented at the Revolutionizing Atopic Dermatitis (RAD) 2025 conference held in Nashville, Tennessee.

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IDStewardship

JUNE 19, 2025

Authored By: Aneeka Chavda, MRPharmS, MSc, MCMI, PgDipClinPharm Posted 19 June 2025 Mycobacterium tuberculosis (TB ) is one of the leading causes of death globally. In 2014, the US FDA approved this regimen, and it features in the latest WHO guidelines for LTBI treatment. The WHO reports that in 2023, around 10.8 million fatalities.

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Pharmacy Times

JUNE 20, 2025

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Accessed May 15, 2025. Accessed May 15, 2025. Accessed May 15, 2025. Accessed May 15, 2025. August 8, 2024.

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Pharmacy Times

JUNE 20, 2025

In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Accessed May 12, 2025. Accessed May 12, 2025. Accessed May 12, 2025. Accessed May 12, 2025.

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