Drug Topics

JUNE 17, 2025

By acting on hair follicle stem cells—which remain present even in balding areas—PP405 offers a promising option for people often left out by existing therapies. After the randomized portion of the study, patients were eligible to enroll in an open-label extension study for 3 months to assess the long term safety of PP405.

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Specialty Pharmacies Compounding Independent Pharmacies Immunization 324

IDStewardship

FEBRUARY 12, 2025

time-dependent, concentration-dependent), how much drug reaches the site of infection, the level of antibiotic resistance that is present (i.e., coli labeled as susceptible in 2010 may be labeled as resistant in 2025. Picking an antibiotic depends on the how the antibiotic kills bacteria (e.g., allergies, drug interactions).

Labelling 130

Labelling 130

Fierce Pharma

FEBRUARY 6, 2024

On a day when Vertex revealed trial data that indicate | On a day when Vertex revealed trial data that indicate its next-generation cystic fibrosis (CF) treatment will soon be ready to grab the baton, the Boston company also presented figures that show Trikafta remains formidable. In the fourth quarter, Trikafta raked in $2.33

Labelling 103

Labelling 103

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). FDA Guidance , at 8 (emphasis added). Now, guidances are generally not legally binding, unlike statutes or regulations.

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FDA Documentation Labelling 105

Fierce Pharma

OCTOBER 16, 2024

While radiopharmaceuticals have attracted significant interest in recent years thanks to their cancer-fighting prowess, the unique makeup of the meds has presented a host of production challenges f | SpectronRx has inked an agreement to complete its first European radiolabeling plant at the Belgian Nuclear Research Center in Mol, Belgium.

Labelling 104

Labelling 104

Pharmaceutical Technology

NOVEMBER 18, 2024

At AHA 2024, clinical trial results were presented from the ongoing open-label extension trial, LIBERATE-OLE, involving lerodalciep.

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Labelling 52

Fierce Pharma

OCTOBER 11, 2023

Dermavant has presented evidence that Vtama provides immediate and long-term relief from the severe itch condition pruritus, the most prevalent symptom of atopic dermatitis. The trial results bolster Dermavant's effort to win a label expansion for the drug.

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Labelling FDA 109

Pharmaceutical Technology

JUNE 12, 2024

Written Medicine is a digital solution that provides bilingual dispensing labels, described in a presentation at the NHS ConfedExpo conference in Manchester.

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Labelling 52

IDStewardship

APRIL 16, 2025

Many attendees come to present their research and explore emerging technologies. Each bottle was labeled with the data point and the year. I found myself staring at this graphic, which was completely motivated by the visual appeal of presenting data in such a way. Some people describe it as a European version of IDweek.

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Labelling Communication 130

Fierce Pharma

DECEMBER 21, 2023

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. |

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FDA Labelling 106

STAT

OCTOBER 26, 2022

But in the field of addiction medicine, the question presents something of a crisis. Even as drugs and alcohol claim 200,000 lives each year, many who seek addiction treatment are greeted by the harsh, stigmatizing labels that many Americans don’t think twice about: Words like addict, alcoholic, junkie, abuser, or worse.

Labelling 112

Labelling 112

The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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Labelling FDA Documentation 52

European Pharmaceutical Review

JANUARY 25, 2023

Participants were enrolled into an open-label phase of the study, which enabled the assessment of durability of antidepressant effect, as well as the comparative efficacy and safety of a one versus two dose regimen of SPL026. No drug-related serious adverse events (SAEs) reported, including no reported suicidal ideation or behaviour.

Labelling 133

Labelling 133

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. All medicines on the UK market must be labelled as for sale only within the UK, including in Northern Ireland.

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Packaging Labelling 105

pharmaphorum

DECEMBER 5, 2022

A vast majority of patients diagnosed with CRPC already present with metastases at the time of diagnosis. The findings will be presented at an upcoming medical meeting and submitted to the FDA for regulatory approval in 2023. Prostate cancer is the most frequently diagnosed cancer in men in 112 countries.

Chemotherapy 59

Chemotherapy Compounding Labelling FDA 59

The Checkup by Singlecare

JULY 7, 2025

Off-label use or cycling of up to 700 mg of testosterone weekly can cause hair loss.” Testosterone enanthate and cypionate drug interactions and warnings Many side effects can be bothersome, but tolerable. However, “the majority of patients on TRT experience few or no side effects when appropriately dosed and monitored.

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Labelling Insurance Dosage Insurance Coverage 52

European Pharmaceutical Review

JUNE 26, 2025

Nine patients with advanced adenocarcinomas received a single treatment cycle of the drug candidate 177 Lu-labeled FAPI-RGD. The findings were presented at the Society of Nuclear Medicine and Molecular Imaging 2025 Annual Meeting and published in the Journal of Nuclear Medicine. percent of patients. Xiang et al.

Labelling 52

Labelling Hospitals 52

pharmaphorum

OCTOBER 14, 2022

” The programme has been set up to develop four devices – an e-paper label, smart wearable sensor, smart pill box, and endo-cutter used in surgical procedures – with funding from the EU’s Horizon Europe programme and support from the Waste Electrical and Electronic Equipment (WEEE) Forum. .”

Labelling 124

Labelling 124

European Pharmaceutical Review

NOVEMBER 21, 2022

The Modulation of SERCA2a In Cardiomyopathy (MUSIC) HFpEF (MUSIC-HFpEF1) clinical trial will enrol patients in an open-label, dose-escalation, 52-week Phase Ib/IIa clinical trial, assessing the safety and clinical efficacy of the intra-coronary infusion. The syndrome accounts for half of all heart failure cases globally.

Labelling 139

Labelling FDA 139

The FDA Law Blog

OCTOBER 24, 2023

The SIUU Guidance introduces two new concepts that are of note to industry regarding information it may choose to disseminate under this “safe harbor:” 1) application to firm-generated presentations of scientific information; and 2) material that meets a new evidentiary standard – scientifically sound and clinically relevant.

Labelling 64

Labelling FDA Communication 64

Hospital Pharmacy Europe

AUGUST 10, 2023

Although two-person checking is a common practice in many areas of healthcare, the preparation of medication that includes the transfer from labelled ampoules into unlabelled syringes is normally a sole pursuit undertaken by an anaesthetist. of administrations during anaesthesia.

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Labelling Pharmacy Procurement Hospitals 97

European Pharmaceutical Review

JUNE 28, 2022

The Phase III Asclepios I/II trials and the Alithios open-label extension from Novartis , showed that earlier initiation with Kesimpta resulted in a more than three-fold increased likelihood of maintaining NEDA-3 throughout the study. The data were presented at the 2022 European Academy of Neurology (EAN) Annual Meeting.

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Labelling Hospitals 98

IDStewardship

OCTOBER 14, 2024

Read all about this in the product label here. More information on ganciclovir in the label here. Disclaimer: The views and opinions presented in this article represent those of the author and do not necessarily reflect the policy or position of any previous, current, or potential future employer. Well, maybe not.

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Compounding Labelling Packaging Hospitals 130

Pharmaceutical Technology

AUGUST 10, 2022

Presently, the therapy is being analysed in late-stage studies. The Reliance programme also comprises a long-term, open-label safety trial, Reliance-OLS, which is enrolling subjects who have completed the three trials, as well as de novo subjects.

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FDA Labelling 119

IDStewardship

MARCH 12, 2023

Side note, I also have learners watch this video from CIDRAP-ASP which is a presentation by Brad Spellberg. ” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication.

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Medication Guidelines Documentation Labelling Hospitals 299

The Checkup by Singlecare

NOVEMBER 5, 2024

Because they have different approved indications from the Food and Drug Administration (FDA) and off-label uses , Eliquis and Plavix are not considered competitors. when used with aspirin Source: Eliquis and Plavix drug labels. Patients going for surgery present a problem. Frequency Major bleeding Yes 2.13% per year Yes 3.7%

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Labelling Insurance FDA Dosage 52

European Pharmaceutical Review

JANUARY 20, 2023

Clinical success begins early for small molecule drugs The MHRA authorisation for MZL is based on results from the multicentre, global, single-arm, open-label, Phase II MAGNOLIA trial in patients with R/R MZL who received at least one anti-CD-20 based regimen. “As

Labelling 119

Labelling Hospitals 119

European Pharmaceutical Review

SEPTEMBER 20, 2022

In the ongoing open-label, longitudinal SHORELINE Study in MDD, the median time to the first repeat treatment course for those patients who responded to the initial 14-day treatment course was 135 days for the completed 30mg cohort (n = 489) and 249 days for the ongoing 50mg cohort (n = 146).

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Labelling 98

The Checkup by Singlecare

JANUARY 10, 2025

Although gabapentin is an anticonvulsant , its often used off-label to treat restless legs syndrome (RLS) and other nerve conditions or neuropathic pain. Id recommend testing taking the medication when another adult is present to observe how you respond. Gabapentin is a prescription medication used to treat nerve pain and epilepsy.

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Dosage Labelling Hospitals 98

Hospital Pharmacy Europe

JANUARY 16, 2025

Here, lead author and focus group chair Hala Fadda discusses the reasons for widespread off-label prescribing, the FIP studys rationale and main findings, compounding challenges and considerations for improving clinical practice. Compounding liquids that are stable and acceptable to paediatric patients present some of the greatest challenges.

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Compounding Labelling Dosage Hospitals 119

European Pharmaceutical Review

NOVEMBER 1, 2022

The Phase III open-label, randomised trial ( NCT03682536 ) evaluated the efficacy and safety of Reblozyl versus epoetin alfa. BMS will do a full evaluation of the clinical trial data and work with investigators to present results at an upcoming medical meeting. The company will also discuss results with health authorities.

Labelling 105

Labelling 105

European Pharmaceutical Review

SEPTEMBER 26, 2023

Patients who experienced disease progression while having a placebo treatment were offered resminostat in an open label treatment arm. The data from the resminostat study was presented at the 2023 EORTC Cutaneous Lymphoma Tumour Group Annual Meeting, at the Leiden University Medical Center Amsterdam.

Labelling 110

Labelling 110

European Pharmaceutical Review

MARCH 5, 2024

Conference, forums and highlights Parallel to the fair, the renowned analytica conference takes place in the ICM – International Congress Center Messe München, covering the breadth of modern analysis with around 180 presentations. ” Additionally, environmentally friendly alternatives to chemicals and consumables are presented.

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Labelling FDA 98

Pharmaceutical Technology

APRIL 17, 2023

However, the treatment’s label features a black box warning that includes increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. He added that there is also a need for FDA-approved products that communicate efficacy and safety on their labels.

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FDA Medical Schools Labelling Communication 96

Viseven

JUNE 18, 2025

Drug development Medical affairs experts provide ongoing support throughout the drug development cycle, from gathering insights from HCPs and patients to monitoring safety signals and therapeutic trends to identify new indications or label expansion opportunities.

Labelling 52

Labelling Communication Documentation Pharmaceutical Companies 52

Hospital Pharmacy Europe

JUNE 9, 2023

The combination of ribociclib and standard endocrine therapy improves invasive disease-free survival rates more than endocrine therapy alone in patients with early stage, hormone receptor–positive, HER2-negative (HR+/HER2-) breast cancer, according to recent data presented at ASCO 2023.

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Dosage Labelling Hospitals 98

The Checkup by Singlecare

MAY 27, 2025

By showing itself to be at least as effective and safe as the existing option, warfarin , Xarelto presented a new therapeutic option for this critical and all too common need. This presents a major benefit over warfarin, which requires frequent blood tests to ensure the proper amount of anticoagulation. Is Xarelto right for you?

Labelling 52

Labelling FDA 52