PharmTech

JUNE 19, 2025

link] Recent Videos Related Content FDA Voucher Program Provides Shorter Drug Application Review Time Susan Haigney June 18th 2025 Article The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time. Pharmaceutical Technology 2025 49 (4).

Dosage

The Checkup by Singlecare

MARCH 20, 2025

Tablet Regular, chewable, delayed-release, or buffered oral tablets; or suppository What is the standard dosage? The degree of risk of these bleeding events is dependent on an individuals risk factors such as age and frequency of falls. Their utility, side effects, drug interactions, and FDA warnings are distinct.

Insurance

PharmExec

AUGUST 1, 2025

Author(s): Nicholas Jacobus Key Takeaways Vizz, an aceclidine-based eye drop, is FDA-approved for presbyopia, enhancing near vision without myopic shifts. SHOW MORE LENZ Therapeutics celebrates FDA approval of Vizz, the first aceclidine eye drop for presbyopia. I want to thank each of them for their role in getting Vizz FDA approved.”

FDA

Pharma Manufacturing

JUNE 17, 2025

Despite the potential efficiencies and the FDA encouraging manufacturers to make the switch from batch processing, the pharmaceutical industry has been slow to adopt continuous manufacturing due in large part to general conservatism and the cost implications of such investments. “Those are through the FDA,” he said.

Dosage

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

The Checkup by Singlecare

DECEMBER 31, 2024

He warns that dosing these drugs together increases the risk of adverse events. Vyvanse and Adderall are both approved by the Food and Drug Administration (FDA) for ADHD and belong to the same drug class. They have FDA black box warnings due to their high risk of abuse and misuse. The effects of Vyvanse last up to 14 hours.

FDA

Pharmacy Times

JULY 22, 2025

Importantly, Novavax received FDA approval in May 2025 with restrictions: It is approved for individuals 65 years and older and patients aged 12 to 64 years with at least 1 health condition that puts them at risk for severe COVID-19. link] Seasonal influenza vaccine dosage & administration. October 16, 2024. Accessed May 29, 2025.

Vaccines

The Checkup by Singlecare

APRIL 4, 2025

Food and Drug Administration (FDA) to treat major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder. The FDA warns that people should avoid alcohol while being treated with venlafaxine, as combining them can be dangerous and worsen side effects. Its specifically approved by the U.S.

Dosage

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. If gabapentin is suspected to be a contributing factor to ED, we may explore alternative treatment options or adjust the dosage.

Adverse Reactions

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

DECEMBER 30, 2024

Regarding the additional utility, telmisartan and losartan have different approved uses from the Food and Drug Administration (FDA). Tablet Tablet What is the standard dosage? 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.

Insurance

Pharmacy Times

AUGUST 7, 2025

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

Labelling

PharmaVoice

JUNE 27, 2025

Despite worried hand-wringing over a potential slowdown in FDA approvals under the new administration, the agency has been giving the go-ahead to drugs at a near record-setting clip. Meanwhile, the decision-making production has come during a major upheaval inside the FDA. Please let us know if you have feedback.

FDA

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

PharmTech

JUNE 6, 2025

These may either be specific to the production process itself (such as pyroglutamination of the N-terminus as is frequently seen in monoclonal antibodies (mAbs) or may be the result of purification processes (such as amino acid oxidation or deamidation events) and may indicate that process change is required. Specifications.

Dosage

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. The table below focuses on the most common alternatives to Contrave.

Controlled Substances

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 ). It is not an FDA-approved anxiety treatment, and of the beta blockers prescribed off-label for anxiety, Bystolic is not the most common. Bystolic is FDA-approved for high blood pressure , not anxiety.

Labelling

Pharmacy Times

JUNE 20, 2025

Selection of an appropriate OTC analgesic should take into consideration various patient factors, including the patient’s overall health status, current medical conditions, and medication profile, as well as patient preferences, which are often influenced by dosage form, required dosing intervals, and cost of OTC medication.

Compounding Pharmacies

Pharmacy Times

JUNE 25, 2025

Despite its proven efficacy, the conventional oral administration of lenalidomide presents challenges due to its short half-life and the high systemic exposure required to sustain therapeutic drug levels, which can lead to significant toxicities, particularly grade 3 or 4 hematologic adverse events (AEs).

Immunization

PharmTech

AUGUST 11, 2025

New manufacturing methods are also being explored to enable more personalized and patient-centric dosage forms, such as 3D printing of oral solid dosage (OSD) drugs. Tailoring medicines to improve outcomes Personalized OSD forms aim to improve outcomes and adherence by tailoring medicines to each patient’s needs.

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

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

Pharmacy Times

JUNE 17, 2025

A group of experts will present an encore abstract titled " Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using Real-World Data " at the 2025 Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20.

Dosage

Pharmacy Times

JUNE 17, 2025

Among the 37 practices that reported waste, 768 events were reported, leading to a total drug waste of $11,275,642.16. These events foster innovation, collaboration, and professional growth within the oncology pharmacy community. compared with $546,082.45 for the external mail-order pharmacies. Of that, $8,935,612.15

Mail-Order Pharmacies

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

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). In addition, many patients are hesitant to receive eye injections.

Dosage

Pharmacy Times

JUNE 27, 2025

Image credit: Shutter2U | stock.adobe.com Biosimilars are biologic products highly similar to an FDA-approved reference product, with no clinically meaningful differences in safety, purity, or potency. Misconceptions can lead to unnecessary hesitation, increased health care spending, and reduced access to important biologic treatments.

Compounding Pharmacies

Pharmacy Times

JULY 4, 2025

2 There are several FDA-approved adalimumab biosimilars—including interchangeable products—that are available to patients. Both Hadlima and Hyrimoz share the same strengths and dosages and have no clinically meaningful differences from Humira when relieving patient symptoms.

Specialty Pharmacies

PharmTech

JUNE 23, 2025

Pharmacist weighing chemical | Image Credit: © Kzenon - stock.adobe.com Performing calculations for the formulation of pharmaceutical dosage forms and related preparations is a key activity in compounding. Active moiety calculations determine the drug amount needed to prepare the dosage form quantity. Policy-exception salts.

Compounding

Pharmacy Times

AUGUST 7, 2025

Side effects can interfere with daily life, reduce quality of life, and even cause patients to reduce the dosage or discontinue the drug completely.¹ Up to 87% of individuals who take opioids for a long period time say they have OIC. This real‑world evidence underscores the importance of informed selection and cautious prescribing.

HIV Treatment and Prevention Agents

Pharmacy Times

JUNE 9, 2025

FDA approval of LIMITX for broader use could significantly impact opioid misuse prevention and save lives. Or, as FDA officials like to call it, “multiple tablet ingestion”—I guess it sounds better to them. trillion economic impact in 2020. SHOW MORE A novel solution can strategically control the release of the drug in vivo.

Compounding Pharmacies

Pharmacy Times

JULY 22, 2025

By incorporating a patient's genetic profile into therapeutic decision-making, pharmacists can identify optimal drug choices and dosages while minimizing the risk of adverse events (AEs). This is particularly vital in polypharmacy scenarios, where the risk of drug-drug interactions and cumulative toxicity is high.

Compounding Pharmacies

Pharmacy Times

JUNE 10, 2025

Meloxicam injection (Xifyrm; Azurity Pharmaceuticals, Inc) received FDA approval for use in adults for the management of moderate-to-severe pain, either alone or in combination with non-steroidal anti-inflammatory drug (NSAID) analgesics. The approval offers patients a new intravenous (IV) formulation of meloxicam.

HIV Treatment and Prevention Agents

Pharmacy Times

JULY 17, 2025

Despite observational evidence, causation is not established, necessitating further research on dosage effects and neurocognitive outcomes. The study emphasizes the importance of pharmacist involvement in monitoring cognitive risks and managing long-term gabapentin therapy.

Compounding Pharmacies

Pharmacy Times

JUNE 20, 2025

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Compounding

The Checkup by Singlecare

JULY 15, 2025

The intensity of a statin depends on both the drug and its dosage: Low-intensity statins lower LDL-C by less than 30%. 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. Moderate-intensity statins lower LDL-C by 30–49%.

Labelling