The FDA Law Blog

JANUARY 9, 2025

to take photographs as necessary; to collect samples; talk to pertinent staff ; or to collect food labels and labeling). But a recent Warning Letter raises new questions for regulated companies on whether FDA can interview company employees, and if so, how companies should handle these requests during an inspection.

FDA

The Checkup by Singlecare

DECEMBER 30, 2024

According to a 2024 study in Animals, gabapentin is also safe and well-tolerated for dogs with behavior disorders. Additionally, gabapentin is typically used as a human medicine; its prescribed off-label for dogs since it doesnt have FDA approval for them yet. It can help treat seizures and relieve anxiety.

Dosage

European Pharmaceutical Review

NOVEMBER 1, 2024

percent between 2024 and 2033. Otherwise, advanced technological features such as “Advanced Recycling PET or Carbon Capture PET” as well as “labelling and sensory tracking systems” offer opportunities too, Towards Packaging asserted. The worldwide pharmaceutical container packaging market is expected to rise in revenue from $104.12

Packaging

The Checkup by Singlecare

APRIL 9, 2025

For instance, in 2024, Ozempic was covered under Aetna s Advanced Control Plan and Standard Plan. Though some healthcare providers prescribe it off-label for obesity, Ozempic is not FDA -approved for weight loss. … In my experience, it is not covered for off-label use. And if so, how much does Aetna cover the drugs cost?

Insurance Coverage

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

Hospital Pharmacy Europe

MARCH 11, 2025

Neil has been funded by NIHR to investigate the best way to treat patients incorrectly labelled as allergic to penicillin , and how to integrate this decision-making process into routine clinical practice. This is something Neil has first-hand experience in, and he has seen positive change as a result.

Hospitals

The Checkup by Singlecare

MARCH 11, 2025

In a 2024 KFF survey, one out of every eight Americans said they had taken a GLP-1 drug like semaglutide. Some healthcare providers might prescribe it off-label for weight management as well. Additionally, a 2024 study in Diabetes Epidemiology and Management found that oral semaglutide reduced hemoglobin A1C by an average of 3.1%.

Compounding

Pharmaceutical Technology

JUNE 26, 2025

Indeed, in 2024, the Nobel Prize in Chemistry was awarded to the DeepMind team for their work on AlphaFold [ii] , an AI system that accurately predicts protein structures. It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions. Front Genet. 2020 Jan 9;10:1243. doi: 10.3389/fgene.2019.01243.

Compounding

European Pharmaceutical Review

JUNE 12, 2025

Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models. Internet] 2024. Common challenges and solutions for data quality Missing data : this is an obstacle to accuracy as it omits valuable context and information. This relates also to data discontinuity.

FDA

European Pharmaceutical Review

MARCH 27, 2025

Meanwhile, immigration costs continue to skyrocket, with the 2024 Royal Society report finding that the UKs upfront visa costs are 17 times higher than those of other leading science nations. Equalise: making UK immigration costs competitive The UKs visa fees have been labelled as national self-harm by the House of Lords. References 1.

Pharmaceutical Companies

Pharmacy Times

JUNE 27, 2025

5 Phase 3 ECHO Trial: A New Frontline Option The approval was supported by data from the phase 3 ECHO trial (NCT02972840), presented at the 2024 European Hematology Association Hybrid Congress. June 21, 2024. Deaths were reported in 5 TN and 6 R/R patients. The trial enrolled 598 patients 65 years or older with TN MCL. Hemasphere.

FDA

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

The Checkup by Singlecare

MARCH 18, 2025

Mounjaro is FDA approved for Type 2 diabetes but is prescribed off-label (for a non-FDA-approved use) for weight loss. It is often prescribed off-label for weight reduction. Ozempic is often prescribed off-label for weight loss. Rybelsus is FDA approved for Type 2 diabetes and is sometimes prescribed off-label for weight loss.

Labelling

Pharmacy Times

JUNE 16, 2025

The FDA approved nemolizumab in December 2024 for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not controlled by topical prescription therapies among individuals 12 and older. May 15, 2024. December 16, 2024. June 6, 2025.

Compounding Pharmacies

The Checkup by Singlecare

MARCH 4, 2025

Although phentermine is FDA approved for short-term use only, healthcare providers sometimes prescribe it off-label (for non-FDA-approved use) for long-term weight management. While both drugs are effective, a study published in December 2024 found that, on average, people who used Zepbound lost an average of 20.2%

Insurance Coverage

Pharmacy Times

JUNE 30, 2025

Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. Still, providing accurate product labeling for these products—which properly conveys the risks of CRS and neurological toxicities—remains essential to ensuring patient safety. Last Updated November 11, 2024.

FDA

PharmTech

JULY 4, 2025

While treatments for infection, inflammation, high eye pressure, and neovascularization have been shown to be effective, this method of delivery is considered “off-label,” as FDA has not approved products specifically for this use, except two intracameral implants (see below). 2024 11 (2), 179. Times 2024 49 (11). 2024 8 (5).

Dosage

Pharmacy Times

JULY 10, 2025

If approved, lumatperone’s expanded label could offer health care teams a valuable tool to improve stability, well-being, and real-world outcomes for patients with schizophrenia. 1-3 REFERENCES 1. Johnson & Johnson.

FDA

Hospital Pharmacy Europe

APRIL 14, 2025

The National Child Mortality Database report on child deaths related to asthma and allergies was released in December 2024, providing sobering insights. Of those, the most common factor was unclear, misleading, or inaccurate food labelling (either packaged or cooked, bought from supermarkets or takeaways). Accessed March 2025].

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

Pharmacy Times

JULY 15, 2025

December 3, 2024. July 10, 2025. Doi:10.1182/blood.2024026216 2024026216 3. Study shows comparable safety, efficacy of idecabtagene vicleucel in older patients. Pharmacy Times. Accessed July 15, 2025. Real-world data provide a CARbon copy for ide-cel. July 10, 2025. Doi:10.1182/blood.2025029274

Immunization

Pharmacy Times

JULY 22, 2025

This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options. billion in July 2024. Four others have been acquired, including Tobira Therapeutics, acquired by Allergan for up to $1.7

Compounding Pharmacies

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. August 8, 2024. Updated January 19, 2024. LinkedIn Workplace Learning Report 2024. American Oncology Network.

Compounding

The Checkup by Singlecare

JUNE 25, 2025

Centers for Disease Control and Prevention (CDC) , 2024) Type 2 diabetes in the U.S. CDC , 2024) The percentage of people with severe obesity, defined as a BMI of 40 or higher, is slowly growing: It was 9.7% CDC, 2024) How many people use Mounjaro for Type 2 diabetes? KFF , 2024) How many Americans use insurance for Mounjaro?

Insurance

Pharmacy Times

JULY 2, 2025

2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis. November 11, 2024. The trial’s primary objective was to evaluate the tolerability of OLC at its clinically effective doses (goal: serum phosphate ≤ 5.5 News release.

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

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. 4 Detect-A-Dose features a contrasting black and white pattern on the underside of its label to make missing doses for patients apparent to pharmacists. Pharmacist.

Packaging

The Checkup by Singlecare

APRIL 15, 2025

It is also commonly used off-label for weight loss because, as a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, tirzepatide helps control appetite (and thereby facilitates weight loss) in addition to lowering blood sugar. So, why is compounded tirzepatide even available?

Compounding

Drug Topics

JULY 7, 2025

Patients were 18 years and older with type 2 diabetes and were included from January 1, 2015, through June 30, 2024. 2 One of the risks of SGLT2is has been an increase in hematocrit levels, ranging from 2.3% in clinical trials, according to a case series published in Endocrine Abstracts. in the DPP-4i group and decreasing to 3.5%

Compounding

PharmaShots

JUNE 11, 2025

. & ongoing, as of Oct 2024 (mFU: 19mos.); as of Oct 2024 (mFU: 19mos.); in label Ref: Nuvationbio | Image: Nuvationbio | Press Release Related News:- BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors PharmaShots!

Labelling

The Checkup by Singlecare

JUNE 5, 2025

Because of those effects, Mounjaro is sometimes prescribed off-label for weight loss. RELATED: Zepbound vs. Mounjaro │ Wegovy vs. Ozempic “In some cases, insurance may cover Mounjaro for weight loss, even though it’s off-label,” Dr. Melamed says. Medicare and Medicaid costs vary by plan as well.

Insurance Coverage

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. 105288 (Dec.

Labelling

The Checkup by Singlecare

JUNE 25, 2025

In 2024, Wegovy was also approved to reduce the risk of cardiovascular events in adults who are overweight or have obesity. In May 2024, Novo Nordisk, the manufacturer of Wegovy, reported that more than 25,000 Americans each week were starting to take the weight loss medication at the time. million times in the month of February 2024.

Insurance Coverage

Pharmacy Times

JULY 18, 2025

The sBLA for glofitamab in combination with GemOx in R/R DLBCL was accepted by the FDA in December 2024. December 4, 2024. The dual targeting brings the T cell in close proximity to the B cell and then activates the release of proteins from the T cell that kill cancer cells. News release. Accessed July 18, 2025.

FDA

Pharmacy Times

JUNE 11, 2025

Its efficacy was evaluated in the 2 multicenter, single-arm open-label phase 2 clinical trials TRUST-I (NCT04395677) 3 and TRUST-II (NCT04919811). In TRUST-II, treatment with taletrectinib achieved a cORR of 62%, and as of October 2024 (the time of data cut-off), the median DOR was 19.4 Updated November 21, 2024.

FDA

The Checkup by Singlecare

JULY 2, 2025

This medicine, approved in 2024 , targets a thyroid receptor in the liver, reducing fat, inflammation, and scarring. Other medications may be used off-label to manage fatty liver disease or treat other conditions associated with the disease, such as diabetes and obesity.

FDA

Pharmacy Times

JUNE 12, 2025

Updated November 4, 2024. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). 4 REFERENCES 1. A phase 3 single-arm study of UGN-102 for treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (ENVISION).

FDA