Pharmaceutical Technology

JUNE 25, 2025

The updated label for GE HealthCare’s positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug’s effectiveness. Don’t let policy changes catch you off guard.

Labelling

Pharma Marketing Network

JUNE 14, 2025

FDA Frontlines” A reliable resource for regulatory professionals, FDA Frontlines keeps tabs on advisory committee decisions, label expansions, and safety communications. From cold chain logistics to sustainability in packaging, it offers crucial insights for manufacturing and operations leaders.

Communication

SingleCare

JULY 7, 2022

Flaws in the manufacturing process can cause some drugs to be contaminated, ineffective, or labeled incorrectly. To prevent potential adverse events and protect public health, the FDA has implemented drug recall processes to obtain, replace, and dispose of defective, incorrectly labeled, or ineffective drugs.

Documentation

The Checkup by Singlecare

AUGUST 7, 2025

This is called an authorized generic , meaning it is the exact same drug packaged without the brand name. What are the off-label uses for Symbicort? But Dr. Freiss says it can be used off-label as a rescue inhaler as well, allowing people to only carry one inhaler instead of two. gm of 160/4.5 mcg/act inhaler $549 for 1,10.2

Insurance

Pharmaceutical Technology

AUGUST 13, 2025

GlobalData pharma analyst Vinie Varkey says: “Brinsupri represents the first on-label non-antibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly shift away from use of antibiotics in this disease space.” However, until now, there has been no therapy specifically approved for the condition.

FDA

The Checkup by Singlecare

AUGUST 7, 2025

Choose piping-hot, freshly cooked meals when available; otherwise, choose pre-packaged foods. Avoid raw produce (unless it has an intact peel and you can wash it yourself with bottled water). Skip street vendor food in areas that may have limited food safety oversight.

Immunization

Pharmaceutical Technology

JUNE 26, 2025

It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions. Through advanced AI-driven data curation, the platform extracts real-world insights from clinician notes, including reasons for GLP-1 therapy discontinuation such as adverse events and perceived lack of efficacy.

Compounding

Pharmaceutical Technology

AUGUST 5, 2025

As protection against gonorrhoea is not currently a licensed indication for the 4CMenB vaccine in England, the programme utilises off-label use of the vaccine. Evaluating immunogenicity data and a cost-effective modelling analysis, the panel recommended a targeted vaccination programme 4CMenB in those at the highest risk.

Vaccines

PharmTech

JUNE 6, 2025

In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling. MS provides mass information allowing identification of N-glycan compositions.

Dosage

Hospital Pharmacy Europe

APRIL 14, 2025

Of those, the most common factor was unclear, misleading, or inaccurate food labelling (either packaged or cooked, bought from supermarkets or takeaways). CDOPs recorded factors related to public safety in a third of the anaphylaxis reviews.

Health and Personal Care Stores

PharmTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Part two discussion describes a simple medication order and demonstrates calculations and labeling for each bulk drug type. Pluta Nishant B. Mole calculations.

Compounding

The Checkup by Singlecare

MAY 12, 2025

It has several off-label uses, too, including treating chronic constipation, constipation related to irritable bowel syndrome (IBS), bowel preparation for colonoscopy procedures, and treating constipation in children (which the American Academy of Pediatrics considers safe). Follow the dosing instructions on the package and be patient.

Packaging

The Nontraditional Pharmacist

JULY 1, 2025

And ultimately, it’s to ensure we get the data because the data are ultimately what turns into your FDA approved label and demonstrates what you need. Sometimes we exclude medications from our protocol, various CYP enzymes and kind of going through a package insert to see, should we exclude this drug or not?

FDA

Pharmaceutical Technology

JUNE 27, 2025

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.

Labelling

Pharmacy Times

JULY 15, 2025

What we've done is blend PillPack's innovative packaging with Amazon Pharmacy's user-friendly approach and affordability, so these patients can now get their medications in convenient, personalized packets and order everything online through our digital pharmacy.

Compounding Pharmacies

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. Pharmacists must adapt to new tools, ensuring safe medication distribution through improved literacy and teamwork.

Packaging

STAT

JANUARY 15, 2025

A new government proposal to display nutritional labels on the front of food packaging is aimed at helping Americans make more informed choices about what they eat. An eventual side effect, research and expert commentary suggests, could be nudging the food industry to make healthier food, too.

Labelling

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.

Compounding Pharmacies

Pharmacy Times

JULY 3, 2025

It's cognitive behavioral therapy packaged as a digital experience. I've even seen VR experiences, so it can be packaged in any type of digital experience. Typically, it's a white-labeled experience, so it has the look and feel of that digital therapeutic throughout the entire experience.

Compounding Pharmacies

PharmTech

JUNE 12, 2025

The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections.

FDA

Pharmaceutical Technology

JULY 29, 2025

The FDA’s approval for adults with GHD was based on the findings from the Phase III parallel-arm, randomised, active-controlled (open-label) and placebo-controlled (double-blind) foresiGHt trial. This therapy is administered subcutaneously once a week, ensuring a sustained release of active, unmodified somatropin.

FDA

The Checkup by Singlecare

AUGUST 6, 2025

There are currently no FDA-approved medications specifically for prediabetes, but some healthcare providers may prescribe metformin , a diabetes drug, off-label if they believe it’s appropriate. If a healthcare provider prescribes Wegovy for prediabetes, it’s considered off-label use. If they agree, you’ll receive a prescription.

Insurance

The Checkup by Singlecare

MAY 6, 2025

It can be prescribed off-label for certain types of pain, especially severe acute pain or pain caused by cancer. Fentanyl may also be prescribed off-label, meaning for a purpose other than what the Food and Drug Administration (FDA) approved it for. As of Sept. It also comes in patches that you can apply to the skin.

Labelling

Pharmaceutical Technology

JULY 7, 2025

The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. How will RFK Jr’s American dream for vaccines play out? Ekterly has the potential to become the foundational treatment for HAE and our focus now is on delivering it to the people who need it.”

FDA

Pharmaceutical Technology

AUGUST 7, 2025

The FDA’s decision to grant accelerated approval was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma, chosen across five open-label studies. The safety of Modeyso was evaluated in 376 patients across four open-label clinical studies.

FDA

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. Package insert. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets. News Release.

FDA

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.

Health and Personal Care Stores

Pharmaceutical Technology

JULY 8, 2025

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

Packaging

Pharmaceutical Technology

JULY 8, 2025

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

Packaging

Pharmaceutical Technology

JUNE 30, 2025

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.

Packaging

The Checkup by Singlecare

JULY 3, 2025

The Wegovy package insert says 4% of people taking Wegovy during clinical trials reported anxiety as a side effect. Your healthcare provider can still write a prescription for these medications to help you lose weight, but your health insurance may not cover them for off-label use.

Insurance

Pharmaceutical Technology

JUNE 23, 2025

Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Like Eylea, Vabysmo is approved for a range of retinal diseases but has higher uptake due to the longer intervals between injections, giving it market advantage. Sign up for our daily news round-up!

Communication

Pharmaceutical Technology

JULY 15, 2025

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

Packaging

Pharmaceutical Technology

JULY 15, 2025

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

Packaging

PharmTech

JULY 17, 2025

Stage 1: design the compounding blueprint Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors. Stage 4: packaging & patient-ready delivery Assemble patient/client information equivalent to commercial products.

Compounding

Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.

Communication

Pharmaceutical Technology

JUNE 30, 2025

The agency said that safety information can be adequately conveyed using drug product labelling. How will RFK Jr’s American dream for vaccines play out? This includes a boxed warning for the risks of CRS and neurological toxicities. Give your business an edge with our leading industry insights.

FDA