Hospital Pharmacy Europe

JUNE 19, 2023

Topical roflumilast is being increasingly trialled for a number of skin conditions but how effective is it, and will it take centre stage in the field of dermatology? But how effective is topical roflumilast in the management of skin diseases? Psoriasis management Topical roflumilast 0.3% Rod Tucker investigates. with placebo.

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BioPharm

MAY 25, 2023

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

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Fierce Pharma

DECEMBER 13, 2022

Arcutis' topical cream goes 2 for 2 in pivotal eczema trials to clear path to FDA. Tue, 12/13/2022 - 06:07.

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pharmaphorum

MARCH 10, 2024

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug.

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Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

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pharmaphorum

OCTOBER 26, 2022

Topicals — creams, ointments, foams, and lotions applied directly to the affected areas of the skin — don’t get nearly as much TV time as their systemic biologic counterparts, the self-injectables with catchy theme songs, where the smiley and sleeveless walk confidently down the street and/or swim. First in class. In May, the U.S.

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The Checkup by Singlecare

DECEMBER 6, 2023

These were just a couple of the topics that were popular on The Checkup this year. 10 trending health topics in 2023 We do our best to keep you informed with the health and wellness news you need to live your best, healthiest life on The Checkup and across our social media channels: Facebook , Instagram , X , LinkedIn , and TikTok.

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pharmaphorum

AUGUST 31, 2022

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

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Pharmaceutical Technology

JANUARY 8, 2024

The FDA has granted approval for Ligand Pharmaceuticals’ Zelsuvmi (berdazimer topical gel, 10.3%) for molluscum contagiosum.

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Pharmacy Times

MARCH 27, 2024

The agency warns consumers against using these products, which are marketed for topical use to relieve pain associated with cosmetic procedures.

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STAT

MARCH 8, 2024

The drug, donanemab, succeeded in its Phase 3 trial , resulting in a 35% slowing of Alzheimer’s disease progression versus placebo.

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Pharmaceutical Commerce

DECEMBER 18, 2023

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

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Outsourcing Pharma

DECEMBER 19, 2023

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

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Drug Topics

APRIL 26, 2023

The NexGard COMBO topical solution from Boehringer Ingelheim helps protect cats from tapeworms and other intestinal parasites like fleas, ticks, and heartworms.

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Outsourcing Pharma

JULY 29, 2021

A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.

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The FDA Law Blog

NOVEMBER 28, 2023

Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. Thus, it’s not entirely surprising that FDA would seek input from a panel on this topic. By Allyson B. Mullen & Jeffrey N.

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Fierce Pharma

JANUARY 11, 2024

Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD).

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Pharmaceutical Commerce

DECEMBER 20, 2023

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older.

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ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. However, some of the products manufactured in a topical drug facility can be difficult to clean. Lopolito Steven M.

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Pharmaceutical Technology

JULY 19, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor.

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Drug Topics

DECEMBER 22, 2022

CBD is a hot topic on the internet and social media, but large percentages of posts are making therapeutic claims that are not FDA approved or backed by enough research.

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% to treat the signs and symptoms of dry eye disease.

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pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

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pharmaphorum

SEPTEMBER 28, 2020

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. The post FDA launches Digital Health Center of Excellence appeared first on.

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Drug Topics

JULY 26, 2023

Ycanth (cantharidin) was approved for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older as an in-office administered therapy.

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The FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. FDA Law Blog readers can use discount code S10-866-866L24.S HP&M is proud to have our professionals participating in these important events.

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PharmaVoice

SEPTEMBER 22, 2023

Despite lower-than-expected demand for a competing treatment, DBV’s chief medical officer says the company’s topical skin patch could be a game-changing option for patients.

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Pharmacy Times

OCTOBER 6, 2023

Roflumilast is the first topical agent indicated to treat psoriasis in sensitive intertriginous areas of the skin.

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European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.

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Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Fierce Pharma

OCTOBER 11, 2023

In the race to develop nonsteroidal topical treatments for autoimmune skin conditions, Dermavant is charging toward the finish line—again. 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.

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The FDA Law Blog

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.

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Controlled Substances FDA 64

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% The NDA submission to the FDA was based on positive data obtained from the Phase II and pivotal Phase III trials of roflumilast foam. in patients with seborrheic dermatitis.

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Outsourcing Pharma

MAY 19, 2021

The virtual event (scheduled June 22-24) will feature presentations from Bayer, Merck, GSK, Novartis, Takeda, FDA, WHO, and other notable organizations.

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The Checkup by Singlecare

FEBRUARY 20, 2024

Topical therapies, like corticosteroids , emollients, and retinoids , have traditionally attacked this disease via anti-inflammatory mechanisms, moisturization, or inhibition of skin cell proliferation, respectively. Vtama offers another topical treatment option to help avoid the topical corticosteroid side effect of skin atrophy or thinning.

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pharmaphorum

FEBRUARY 28, 2022

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB). The post FDA turns down Amryt’s epidermolysis bullosa drug appeared first on.

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