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In 2022, the Advisory Committee on Immunization Practices (ACIP) published updated pneumococcal vaccine recommendations. million adult patients who were enrolled in a health plan as of January 2022 that contributed data to the Optum database. Of those, 38% had evidence of pneumococcal vaccination prior to January 2022.
In 2022, the estimated cost of those diagnosed as having diabetes was $413 billion. 2022 Jun 20;15:1911-1923. Additional advantages include fewer emergency visits, hospitalizations, medication adherence, and associated cost savings. 2 “Prevalence of diabetes in the United States continues to rise, affecting an estimated 38.4
The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications, Iilun Murphy, MD, director of the Office of Generic Drugs in the FDAs Center for Drug Evaluation and Research, said in a statement.
Biotech company NMD Pharma has announced that the US Food and Drug Association (FDA) have granted its Charcot-Marie-Tooth (CMT) disease treatment NMD670 orphan drug designation (ODD). NMD670 was previously granted ODD by the FDA for generalised myasthenia gravis in September 2022.
Updated September 12, 2022. June 20 to 23, 2025. Chicago, Illinois. Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD). ClinicalTrials.gov identification: NCT04161131. Accessed June 23, 2025.
In case you are wondering, the FDA label does not list any hepatic dose adjustments. 2022 Apr;82(5):533-557. The absence of renal dose adjustments may be attributed to sulopenem dual excretion pathways, with elimination occurring through both feces and urine. Chicago, IL: Iterum Therapeutics; 2024. Zhanel GG, et al.
billion in revenue by dispensing medicines to treat cancer, HIV, heart disease, and other serious illnesses at prices that exceeded their estimated acquisition costs between 2017 and 2022. STAT later revealed that Biogen executives recruited an FDA official to help secure the approval. The
Food and Drug Administration (FDA), such as Rybelsus (oral semaglutide), Mounjaro (tirzepatide), Zepbound (tirzepatide), and Saxenda (liraglutide). While a regular pharmacy dispenses commercially manufactured FDA-approved medications, compounding pharmacies prepare customized medications tailored to individual patient needs, says Eric F.
A 2022 study found that both B12 and B5 had protective effects against COVID infection, while a 2020 study found that vitamin B12 (when combined with vitamin D and magnesium) improved outcomes for elderly patients hospitalized with COVID-19. Vitamin C: Vitamin C is well known for its positive effects on the immune system.
The first one approved by the FDA — Mylotarg from Pfizer subsidiary Wyeth for acute leukemia — came to market in 2000. Now, 15 different molecules have been approved by the FDA. It wasn’t always a sure bet that ADCs would break through the noise, though. And the industry doesn’t always move on the right trends.
Daymon, 2022 Private Brand Intelligence Report, May 2023. Our team will be on site to share insights and showcase our portfolio of more than 500 health and wellness OTC products through the Foster & Thrive brand name, including affordable and eco-friendly offerings that reflect today’s consumer priorities. Fred Reichheld. April 2025.
Drug manufacturer Novo Nordisk produces it under the brand name Rybelsus , and the FDA approved it for managing blood glucose in people with Type 2 diabetes but not Type 1 diabetes. Some compounding pharmacies might make semaglutide tablets themselves, but these drugs arent FDA-approved or inspected. mg dose once weekly. at 12 months.
In 2014, the US FDA approved this regimen, and it features in the latest WHO guidelines for LTBI treatment. The rifapentine group had higher treatment completion rates (82.1% versus 69%) than the isoniazid group, mirroring findings from U.S. TB Control Programs 21.
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.
December 2022. News release. Oregon Health and Science University. May 9, 2019. Accessed July 11, 2025. Arkansas Maternal Mortality Review Committee. Legislative Report. Accessed July 11, 2025. Koonin LM, Patel A. Timely antiviral administration during an influenza pandemic: key components. Am J Public Health. 2018;108(Suppl 3):S215-S220.
Its average fiscal year 2022 readmission rate was 23.7%, exceeding the 19.6% The hospital-approved protocol, created in June 2022, granted TOC pharmacists prescribing authority for guideline-directed medical therapy (GDMT), consisting of a 30-day supply of rescue and triple-therapy inhalers, at discharge for patients with AECOPD.
Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. The FDA recently approved generic versions of two other GLP-1s , Victoza (liraglutide) and Byetta (exenatide). Is there a generic for Mounjaro?
May 4, 2022. Isatuximab shows promise in enhancing PFS for patients with multiple myeloma. Pharmacy Times. August 8, 2024. Accessed July 8, 2025. Multiple myeloma. Cleveland Clinic. Accessed July 8, 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.
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). Press Release, March 2, 2022. PLoS ONE 2011 6, e24513.
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. One example of this is a meta-analysis published in Frontiers in Cardiovascular Medicine in 2022.
1,2 To better understand this relationship, researchers assessed 4754 patients with CLL/SLL who were treated with either venetoclax and obinutuzumab from April 2016 to August 2022 (n = 2104) or zanubrutinib from November 2019 to August 2023 (n = 2650).
On February 21, 2020, the FDA approved eptinezumab-jjmr (Vyepti; Lundbeck) as the first intravenous migraine preventative treatment for adults. 1,3 REFERENCES FDA approves Lundbeck’s EPTINEZUMAB-JJMR™ (eptinezumab‑jjmr) — the first and only intravenous preventive treatment for migraine. News release. February 21, 2020. Subscribe Now!
Due to Ozempic’s newsworthy shortages and a growing demand for more GLP-1 drugs, people started talking about Mounjaro in 2022, when it was approved by the Food and Drug Administration (FDA) for the treatment of Type 2 diabetes. Mounjaro was approved by the FDA in 2022 for the treatment of Type 2 diabetes.
2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. In October 2024, CAR T therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) received FDA regenerative medicine advanced therapy designation as a first-line treatment for high-risk large B-cell lymphoma. Accessed February 2025. March 6, 2025.
SHOW MORE Hulio shows comparable efficacy and safety to Humira in treating chronic plaque psoriasis, supporting its FDA interchangeability status. The authors noted that these results support the FDA-granted interchangeability status of Hulio. mL) with high-concentration Humira (40 mg/0.4 mL) with high-concentration Humira (40 mg/0.4
The Food and Drug Administration (FDA) has approved certain opioids for: Relief of mild to moderate severe pain (e.g., The Food and Drug Administration (FDA) has approved certain opioids for: Relief of mild to moderate severe pain (e.g., StatPearls , 2024) Opioid overdose deaths made up 76% of all drug overdose deaths in 2022. (CDC,
Medication Adherence Requires Personalized Communication Alva emphasized that effective counseling about medications—especially those with intimidating FDA warnings—requires compassionate, patient-centered communication.
Only 4% of global drugs sales will have patent protection, compared to 12% and 6% in 2022 and 2024. According to a Reuters article, pharma companies launched new US drugs at prices 35% higher in 2023, compared to those launched in 2022. Biosimilars and generics can be as much as 80% cheaper than branded alternatives.
OTC Use Saves Billions From Cost-Effective Products and Encounters Image credit: Amina | stock.adobe.com A 2022 publication purported $167 billion in savings in ancillary health care cost avoidance through the widespread use of OTC products in the United States. November 2022. REFERENCES The power of OTCs to provide consumer value.
1 Image credit: Cynthia | stock.adobe.com The discussion featured Vivian Fonseca, MD, of the Tulane University School of Medicine, who presented an overview of tirzepatide based on the FDA-approved label and clinical guidelines. FDA Approves Tirzepatide Injection for Adults With Type 2 Diabetes. May 16, 2022. Pharmacy Times.
In 2021, the Food and Drug Administration (FDA) approved Wegovy for weight loss in adults with obesity—or who are overweight with at least one weight-related health condition. In 2022, the approval was expanded to include eligible individuals 12 years and older with obesity. Of those, 34% were adult males and 28% were adult females.
Updated October 6, 2022. FDA approves ropeginterferon alfa-2b-njft for polycythemia vera. REFERENCES 1. Ropeginterferon alfa 2b for early myelofibrosis. Accessed June 30, 2025. ASCO 2025 delivers insights into future of myelofibrosis care. Pharmacy Times. June 3, 2025. Accessed June 30, 2025. November 12, 2021.
The Food and Drug Administration (FDA) may no longer approve the drug based on new safety evidence. Changes in GLP-1 insurance coverage may be due to the rising costs to health plans of the medication and the recent FDA approval of generic versions of Victoza ( liraglutide ) and Byetta ( exenatide ). Contact your insurance company.
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.
SHOW MORE FDA fast-tracks TRE-515 for advanced prostate cancer, combining it with radiation therapy to enhance treatment outcomes and patient care. The FDA has granted fast track designation to TRE-515 (Trethera Corporation), a novel drug, in combination with radiation therapy for the treatment of prostate cancer.
The assertion that prescribing immediate-release opioids longer than two or three months is a red flag may have originated with the Center for Disease Control and Prevention (CDC) 2022 Clinical Practice Guideline for Prescribing Opioids for Pain. Deborah Dowell et al., 1, Recommendation 3. Recommendation 1.
In May 2024, the US Food and Drug Administration (FDA) approved Moderna’s next-generation base-modified mRNA-lipid nanoparticle (LNP) respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345) in adults aged 60 years and older with lower respiratory tract disease (5). Pfizer’s COVID-19 Vaccine Secures First Full FDA Approval.
Wegovy (semaglutide) is a prescription medication that’s approved by the Food and Drug Administration (FDA) to help with weight management in people ages 12 years and older with obesity and in adults who are overweight with at least one weight-related comorbid condition.
2017) In 2022 alone, there were an estimated 534,890 people in the U.S. using Linzess ( ClinCalc , 2022) By 2024, more than 5 million people had been prescribed Linzess since its approval. 2025) From 2022 to 2023, Linzess saw an increase in prescription demand of 10%. million unique patients. Ironwood Pharmaceutical Inc.
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