Drug Topics

AUGUST 2, 2025

The FDA approved a label update for inclisiran (Leqvio), which can now be used as a monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA requested the label update due to data on the therapy’s ability to lower LDL-C.

Labelling

The Checkup by Singlecare

MARCH 20, 2025

The degree of risk of these bleeding events is dependent on an individuals risk factors such as age and frequency of falls. per year Allergic reaction Yes Less than 1% Yes 1%2% Reyes syndrome No N/A Yes Rare Sources: DailyMed Eliquis drug label , StatPearls , and AVERROES trial. per year Yes 3.8%

Insurance

The Checkup by Singlecare

APRIL 9, 2025

That means patients insured under those plans will likely have their Ozempic prescription covered by insurance for Ozempic s FDA -approved purpose: blood sugar management for Type 2 diabetes. Though some healthcare providers prescribe it off-label for obesity, Ozempic is not FDA -approved for weight loss.

Insurance Coverage

The Checkup by Singlecare

DECEMBER 6, 2024

Because clonidine works differently than other blood pressure medications, it also has several off-label uses including anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), and alcohol withdrawal. When taken together, the risk of these adverse events can increase. In addition, alcohol can increase your blood pressure.

Labelling

Pharmaceutical Technology

JULY 29, 2025

The US Food and Drug Administration (FDA) has granted approval for Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, developed as TransCon hGH), a prodrug of somatropin or human growth hormone (HGH), to treat adults with growth hormone deficiency (GHD). Credit: Andrei Kuzmik / Shutterstock.com. Sign up for our daily news round-up!

FDA

The Checkup by Singlecare

FEBRUARY 17, 2025

Its not safe or effective, according to the Food and Drug Administration (FDA), and it may lead to serious health problems. Although these medications are effective, the FDA has not yet approved generic versions, meaning people can only get a prescription for semaglutide under its brand name. Is compounded semaglutide safe?

Compounding

Pharma Marketing Network

JULY 2, 2025

However, every claim must be backed by science and formatted according to FDA and FTC guidelines. Social media marketing strategies in this sector depend on a deep understanding of FDA guidance, adverse event reporting, and promotional labeling limits. Transparency not only ensures compliance but also enhances trust.

FDA

The Checkup by Singlecare

JANUARY 6, 2025

Besides simply lowering LDL, the drug is approved by the Food and Drug Administration (FDA) for reducing the risk of cardiovascular events like heart attacks. Preventing cardiovascular events, such as heart attacks or strokes, from happening or recurring is another salient goal for cholesterol medication.

Dosage

Pharmaceutical Technology

JUNE 25, 2025

The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer’s diagnostics arena. Credit: Utthapon wiratepsupon via Shutterstock. Don’t let policy changes catch you off guard.

Labelling

The Checkup by Singlecare

MAY 27, 2025

The FDA label for Xarelto specifically highlights the risk of bleeding and warns of dangerous spinal hematoma development after spinal anesthesia or puncture. An individuals other medications and health conditions could influence the chance of an adverse event. Brain and intestinal bleeding are the most feared adverse effects.

Labelling

The Checkup by Singlecare

APRIL 9, 2025

Atorvastatin interactions Atorvastatin interactions, per the Lipitor label, include the following: Strong inhibitors of CYP3A4 : Combining atorvastatin and strong inhibitors of CYP3A4, an enzyme, can increase plasma concentrations of atorvastatin. Food and Drug Administrations (FDA) drug recall page. Diarrhea 6.8% Muscle spasms 3.6%

Labelling

The Checkup by Singlecare

JUNE 3, 2025

Calcitriol is FDA-approved to treat calcium deficiency in chronic kidney disease , secondary hyperparathyroidism in chronic kidney disease, and hypoparathyroidism. Off-label, it is also sometimes used to treat rickets, osteomalacia, or calcium deficiencies from other causes.

Labelling

The Checkup by Singlecare

APRIL 18, 2025

In fact, its kind of a jack-of-all-trades drug, approved by the Food and Drug Administration (FDA) to treat epilepsy, postherpetic neuralgia, and restless leg syndrome. Its also prescribed off-label for other types of nerve pain, diabetic neuropathy, mood disorders, and alcohol use disorder.

Adverse Reactions

The Checkup by Singlecare

AUGUST 7, 2025

Seasonal events like picnics, cookouts, and camping increase the chances of improper food handling. Outdoor events like barbecues, tailgates, and picnics often involve long periods where perishable foods sit out unrefrigerated. When temperatures rise, so does the risk of foodborne illness. Summer weather accelerates bacterial growth.

Immunization

Drug Topics

AUGUST 4, 2025

The FDA will now require additional safety label changes to all opioid medications, including the risks associated with long-term use. The FDA will now require additional safety label changes to all opioid medications, including the risks associated with long-term use.

Labelling

SingleCare

JULY 7, 2022

Flaws in the manufacturing process can cause some drugs to be contaminated, ineffective, or labeled incorrectly. For some patients, experiencing a serious adverse event from a drug can be a harrowing, or even life-threatening, event. However, in many cases, the FDA requests or mandates that a drug is recalled.

Documentation

The Checkup by Singlecare

APRIL 4, 2025

Though some people might be tempted to have a drink at a wedding or during dinner with friends, the medication label clearly advises against it. Food and Drug Administration (FDA) to treat major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder. Its specifically approved by the U.S.

Dosage

Pharmacy Times

AUGUST 7, 2025

Labels now emphasize the risks of higher doses and caution against abrupt discontinuation in dependent patients to prevent withdrawal and other harms. SHOW MORE The FDA intends to update opioid labels to highlight risks of addiction, overdose, and interactions, enhancing safety in pain management practices.

Labelling

The Checkup by Singlecare

MARCH 10, 2025

Some are also approved to help lower the risk of heart disease and cardiovascular events in people with diabetes or obesity. It is the active ingredient in the brand-name , FDA-approved drugs Ozempic , Wegovy , and Rybelsus. Novo Nordisk is the only pharmaceutical company that makes FDA-approved medications containing semaglutide.

Compounding

Pharmacy Times

JULY 14, 2025

Dave Randolph | Image courtesy of McKesson The highlight of this year’s event was the announcement of Dave’s Pharmacy in Alliance, Nebraska, as the winner of the Pharmacy of the Year Award, recognizing the pharmacy’s outstanding contributions to patient care and community health.

Independent Pharmacies

The Checkup by Singlecare

DECEMBER 30, 2024

Regarding the additional utility, telmisartan and losartan have different approved uses from the Food and Drug Administration (FDA). Conversely, telmisartan has approval for cardiovascular event risk reduction in patients who are at least 55 years old and at high risk of cardiovascular events. What is losartan?

Insurance

Pharmacy Times

JUNE 27, 2025

SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. The phase 3 ECHO trial showed significant progression-free survival improvement with acalabrutinib, supporting its approval as a new standard of care for untreated MCL.

FDA

Pharmacy Times

AUGUST 8, 2025

The FDA's accelerated approval of zongertinib marks a significant advancement for patients with HER2-mutated NSCLC, offering a new treatment option. Zongertinib's dosing is weight-based, with 120 mg for patients under 90 kg and 180 mg for those 90 kg or more, taken daily until disease progression.

FDA

Pharmacy Times

JUNE 9, 2025

The CheckMate 816 trial showed a high pathological complete response rate without increased adverse events, supporting nivolumab as a standard treatment. A 5-year follow-up confirmed sustained overall survival benefits, with a notable reduction in mortality risk for patients achieving pathological complete response.

Chemotherapy

Drug Topics

JUNE 12, 2025

Image Credit: sonyakamoz - stock.adobe.com "We have been conditioned to equate weight loss with health, and weight loss-resistant individuals are often labeled as failures,” Anat Yaskolka Meir, PhD, postdoctoral research fellow in the department of epidemiology at Harvard Chan School, said in a news release.

Compounding

The Checkup by Singlecare

MARCH 18, 2025

Note that while there are compounded versions of tirzepatide and semaglutide , these drugs are not FDA approved. This article focuses on the five FDA-approved versions of tirzepatide and semaglutide. Tirzepatide is the active ingredient in two medications approved by the Food and Drug Administration (FDA). What is tirzepatide?

Labelling

The Checkup by Singlecare

JULY 28, 2025

Bystolic ( nebivolol ) is a brand-name beta blocker that is FDA approved for treating high blood pressure ( hypertension ). Because this type of drug calms a racing heart by lowering the rate and force of blood pumping through the heart, Bystolic and other beta blockers are sometimes prescribed off-label for anxiety.

Labelling

Pharmacy Times

JUNE 30, 2025

REMS ensured drug safety by requiring certified hospitals to have tocilizumab for severe adverse events management. Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies.

FDA

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. Nemolizumab also received FDA approval in August 2024 as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.

Compounding Pharmacies

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. Specifications.

Dosage

PharmExec

AUGUST 1, 2025

New labels will include study summaries, improved dosage warnings, and information on overdose reversal agents to enhance patient and healthcare professional awareness. New labels will include study summaries, improved dosage warnings, and information on overdose reversal agents to enhance patient and healthcare professional awareness.

Medication Labelling

Pharma Marketing Network

MARCH 18, 2025

Best For: Thought leadership, industry networking, and professional event promotions. Avoiding misleading claims or unapproved off-label promotions. Follow FDA and Regulatory Guidelines Ensure all PPC ads adhere to FDA, EMA, or MHRA regulations. Targeting Options: Job title, seniority, skills, company size, and industry.

Pharmaceutical Companies

Pharmacy Times

JULY 22, 2025

Alixorexton was well-tolerated across all doses, with no serious treatment-emergent adverse events, supporting its further study in a global phase 3 trial. The drug demonstrated dose-dependent enhancements in wakefulness, excessive daytime sleepiness, and cataplexy rates, with significant results at a 6 mg dose.

Compounding Pharmacies

The Checkup by Singlecare

JULY 15, 2025

According to its drug label , patients who need to lower their LDL cholesterol by more than 45% typically start with 40 mg per day. Although 80 mg is the highest dose approved by the Food and Drug Administration (FDA), the benefit from 80 mg over 40 mg isn’t much. Statins are first-line agents for lowering cholesterol.

Labelling

Pharmacy Times

JULY 10, 2025

A recent supplemental new drug application (sNDA) submitted to the FDA seeks to expand lumapeterone’s approval based on compelling relapse prevention data. Long-term relapse prevention remains a cornerstone of effective schizophrenia care.

FDA

The Checkup by Singlecare

MARCH 27, 2025

Food and Drug Administration (FDA) for weight management in adults who are overweight or obese. Contrave has an FDA-mandated black box warning due to the risk of suicidal thoughts and behaviors associated with bupropion, the antidepressant ingredient. It is a combination of phentermine and topiramate in an extended-release capsule.

Controlled Substances

Pharmacy Times

JUNE 23, 2025

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

FDA