The Checkup by Singlecare

JUNE 25, 2025

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. According to 2017–2018 data, about 31% of Americans were classified as overweight. According to the World Health Organization (WHO) , there were about 1.6

Insurance Coverage

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. was over $1 trillion in 2017. As of Sept. Why is fentanyl so dangerous?

Labelling

Drug Topics

JUNE 12, 2025

The FDA approved a label expansion for glecaprevir/pibrentasvir (Mavyret) to treat acute hepatitis C virus (HCV) infection in patients 3 years of age and older with compensated cirrhosis or without cirrhosis, AbbVie announced in a release. 3 READ MORE: Infectious Disease Resource Center Pharmacy practice is always changing.

FDA

Pharmacy Times

JUNE 20, 2025

In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Updated July 14, 2017. 6 REFERENCES 1. Sun protection factor (SPF). Accessed May 12, 2025. Healthchildren.org.

Compounding Pharmacies

The Checkup by Singlecare

DECEMBER 31, 2024

It is approved by the Food and Drug Administration (FDA) to treat hypertension (high blood pressure) and diabetic nephropathy. It also has several off-label uses (uses not approved by the FDA), such as treating heart failure. Losartan is a generic medication used to treat a variety of conditions.

FDA

Drug Topics

JUNE 25, 2025

from 2017 to 2020. of YA with obesity were prescribed OMs—predominantly GLP-1s approved for adults but used off label for younger people. Children today are less active than they used to be—and they’re also facing an increased amount of stress.” 3 Researchers believe more needs to be done to treat obesity among the younger population.

Compounding

pharmaphorum

JULY 7, 2025

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Pharmaceutical Companies

pharmaphorum

JULY 2, 2025

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Pharmaceutical Companies

Pharmaceutical Technology

JUNE 16, 2025

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.

Labelling

pharmaphorum

JUNE 30, 2025

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Vaccines

The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. It issued a draft guidance in 2017 which was subsequently revised in 2019.

FDA

Fierce Pharma

AUGUST 22, 2023

With a new FDA approval to rival Teva's Austedo, Neurocrine Biosciences’ Ingrezza is debuting in a treatment area with hundreds of millions of dollars of revenue potential. | The FDA approved Ingrezza capsules to treat adult with chorea associated with Huntington’s disease.

FDA

pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

FDA

pharmaphorum

FEBRUARY 8, 2021

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. DLBCL is the most common type of NHL in adults, accounting for around a third of the 77,000 new cases diagnosed in the US, according to the FDA.

FDA

pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. Dupixent’s label currently calls for dosing every two weeks for all patients. Leo now says it will start rolling the new product out in February.

FDA

The Checkup by Singlecare

AUGUST 14, 2024

Ozempic (semaglutide) is an injectable drug approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes and reduce the risk of major cardiovascular events in people with Type 2 diabetes and known heart disease. Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017.

Labelling

The FDA Law Blog

MARCH 5, 2024

Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

Labelling

European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). Janssen), a Johnson & Johnson company in December 2017. The partnership deal focused on the development and commercialisation of the immunotherapy CAR-T cell therapy cilta-cel.

FDA

pharmaphorum

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. But it fell short on the secondary endpoint of an improvement of a reduction in the annual rate of moderate to severe exacerabations.

Labelling

STAT

JUNE 29, 2023

He allegedly worked with several other individuals and pharmacies between 2017 and 2021 as part of the scheme. Reconfiguring bottles and labels for distributing medicines is known as misbranding or diverting legitimate prescription drugs. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y.,

Labelling

pharmaphorum

JULY 8, 2021

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Tezepelumab was awarded a breakthrough designation for non-eosinophilic asthma by the FDA in 2018. Results from that programme are due in 2023.

FDA

pharmaphorum

SEPTEMBER 11, 2020

Ocrevus (ocrelizumab) was approved in 2017 for relapsing and primary progressive forms of MS and is seen as one of the most successful drug launches in pharma history, generating sales of $3.79 billion in 2019 with more growth predicted this year.

Labelling

pharmaphorum

MARCH 8, 2021

The new indication for the Merck & Co/MSD-partnered drug – which is also used to treat ovarian, breast and pancreatic cancer – was approved by the EMA last year with a slightly more restricted label than was previous cleared by the FDA.

Chemotherapy

pharmaphorum

APRIL 30, 2021

The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood cancer, a few months after it was submitted to the FDA for the same indication. BMS and bluebird had been hoping for a label allowing third-line use.

Immunization

The Checkup by Singlecare

JANUARY 26, 2024

Approved by the Food and Drug Administration (FDA) in 2017 for blood sugar management, Ozempic has recently gained attention for its weight loss effects. Healthcare professionals prescribe Ozempic off-label for weight management for patients with obesity. It received FDA approval for weight management in June 2021.)

Labelling

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

Insurance

pharmaphorum

MARCH 9, 2022

The launch of Hemlibra (emicizumab) in 2017, with a label expansion in 2018 to broaden its use – had a speedy impact on Eloctate, which also came from Bioverativ’s stable. Sanofi recorded a $2 billion charge in 2019 that it said was largely down to pressure on its drug.

Labelling

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. The post FDA clears first “interchangeable” Humira biosimilar appeared first on.

FDA

The Checkup by Singlecare

FEBRUARY 13, 2023

According to the FDA , eating a balanced diet high in magnesium may reduce your risk of hypertension, but the evidence supporting that claim is still inconclusive. Read the labels. Because the FDA doesn’t regulate supplements for effectiveness or safety, some third-party organizations have taken on that job.

Mayo Clinic

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

FDA

The Checkup by Singlecare

NOVEMBER 8, 2023

You’ve likely heard about Ozempic (semaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist approved by the Food & Drug Administration (FDA) to manage blood sugar levels for people with Type 2 diabetes. It gained approval in 2017 but has surged in popularity recently due to the medication’s ability to help with weight loss.

FDA

pharmaphorum

OCTOBER 14, 2021

The findings were based on an ALITHIOS Phase 3b open-label extension study of Kesimpta, a targeted B-cell therapy that Novartis says, “delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment for MS.”. years vs initiation two years later. billion in 2019.

Labelling

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. Additional concerns for the caregiver include a strain on physical and mental health. What Can Pharma Do?

Labelling

The Checkup by Singlecare

JANUARY 23, 2024

There are no medications with a Food and Drug Administration (FDA) approved indication for muscle relaxation available over the counter in the United States. There is one OTC drug product that is sometimes used off-label (without FDA approval) as a muscle relaxant, and that is guaifenesin. Dantrolene acts directly on the muscle.

FDA

The FDA Law Blog

SEPTEMBER 28, 2023

Walsh — As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs.

FDA

The Checkup by Singlecare

DECEMBER 13, 2024

However, those same effects make these medications an effective off-label treatment for anxiety. Food and Drug Administration (FDA) for anxiety, but they have long been proven effective in helping some people with anxiety. Metoprolol , also sold under the brand names Lopressor and Toprol XL, is one of the available options.

Controlled Substances

pharmaphorum

JANUARY 5, 2023

The deal centres on reSET and reSET-O, Pear’s cognitive behavioural therapy (CBT) based programmes, for people living with substance and opioid use disorders, respectively, which have been approved by the FDA as an adjunct to outpatient treatment.

Labelling