pharmaphorum

DECEMBER 15, 2021

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. The post FDA sets April date for verdict on Incyte’s vitiligo drug appeared first on. million people in the US.

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XTalks

MAY 31, 2022

The spotlight for plaque psoriasis treatment is now on Vtama (tapinarof) cream (one percent), Dermavant’s discovery that has become the first steroid-free topical medication in its class approved by the US Food and Drug Administration (FDA). The Chemical Composition of Vtama.

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XTalks

OCTOBER 24, 2024

Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA). This drug may significantly improve psoriasis care by offering effective long-term control with fewer side effects.

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Research Dermatology Clinical Trials Clinical Trials 105

Pharmaceutical Technology

DECEMBER 5, 2022

Incyte has signed a partnership and licence agreement with CMS subsidiary CMS Aesthetics to develop and market ruxolitinib cream to treat autoimmune and inflammatory dermatologic ailments in Greater China and some Southeast Asian countries.

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XTalks

APRIL 17, 2023

These results are very promising for patients with atopic dermatitis,” said Jonathan Silverberg, MD, professor of dermatology at George Washington University School of Medicine & Health Sciences and co-investigator of the studies, in the company’s press release. ADvocate2 showed similar highly statistically significant results.

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pharmaphorum

SEPTEMBER 2, 2022

Spevigo is the first approved therapy for GPP, and the first drug in the IL-36 inhibitor class to make it through development and onto the market. “We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares,” he said.

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Drugs Antibody FDA Approval Trials 105

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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XTalks

SEPTEMBER 30, 2024

Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024, the study highlighted significant improvements in key disease markers, positioning orismilast as a potential breakthrough in atopic dermatitis management.

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XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

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XTalks

JUNE 17, 2024

Hugel, a Korean medical aesthetics company, recently announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA-wlbg), for the treatment of glabellar lines.

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XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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Gene Therapy Gene FDA Approval Dermatology 97

XTalks

JUNE 26, 2024

The US Food and Drug Administration (FDA) recently approved Botanix Pharmaceuticals’ New Drug Application (NDA) for Sofdra (sofpironium) topical gel, 12.45 The approval of Sofdra provides a much needed solution for individuals struggling with this socially and physically debilitating condition.

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Clinical Trials Clinical Trials Dermatology FDA Approval 103

pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. The post FDA hands Cassiopea its first approval, for acne drug Winlevi appeared first on. Cassiopea spun out of Ireland-domiciled Cosmo Pharma in 2015.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. Source link: [link]

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The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. INDIANAPOLIS , Oct.

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XTalks

JULY 31, 2024

The US Food and Drug Administration (FDA) has just approved Leqselvi (deuruxolitinib), a new oral medication by Sun Pharmaceutical Industries Limited, offering significant hope for those suffering from severe alopecia areata, a condition causing sudden hair loss.

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XTalks

MAY 25, 2023

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. The team discussed Veozah and the benefits of this drug for women’s health. during or after the menopausal transition.

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XTalks

NOVEMBER 2, 2023

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis.

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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XTalks

JANUARY 12, 2024

The US Food and Drug Administration (FDA) has given the nod to Ligand Pharmaceuticals’ topical antiviral Zelsuvmi (berdazimer gel 10.3%) for the treatment of molluscum contagiosum in adult and pediatric patients one year of age and older. The topical gel is the first approved treatment that can be used outside of a medical setting.

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XTalks

MAY 31, 2023

In this episode, Ayesha talked about the FDA approval of the first topical gene therapy for the treatment of a rare skin condition. Krystal Biotech’s Vyjuvek is a topical gene therapy that has been approved for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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Gene Therapy Gene FDA Approval Life Science 52

pharmaphorum

DECEMBER 1, 2021

Current treatments are dominated by generic drugs, and include topical antiseptics, retinoids which work by removing dead skin cells from the surface of the skin but can cause pain and inflammation, and topical antibiotics, as well as hormonal therapies including oral androgen inhibitors like spironolactone or cyproterone.

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pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. The post Dermavant claims its first approval as FDA clears psoriasis drug appeared first on.

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FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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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. million people in the US.

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XTalks

SEPTEMBER 5, 2024

percent ruxolitinib, a topical Janus kinase (JAK) inhibitor, is US Food and Drug Administration (FDA)-approved for the treatment of mild to moderate atopic dermatitis in patients 12 years and older. The initial FDA approval for atopic dermatitis paved the way for the 2022 FDA approval for vitiligo.

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XTalks

SEPTEMBER 22, 2022

On September 1, 2022, Boehringer Ingelheim Pharmaceuticals announced in a press release that the US Food and Drug Administration (FDA) approved Spevigo (spesolimab-sbzo) intravenous injections for GPP flares in adults. Spevigo is the first approved treatment option for GPP in adults. Waldman Department of Dermatology.

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pharmaphorum

OCTOBER 28, 2020

Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts.

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Drugs Sales Marketing FDA Approval 52

pharmaphorum

MAY 18, 2021

Ruxolitinib is a topical Janus kinase (JAK) inhibitor that could provide an alternative to the steroids commonly used to treat these skin conditions, although these drugs have some undesirable side-effects.

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Trials Dermatology FDA Approval Medicine 52

XTalks

DECEMBER 14, 2023

The US Food and Drug Administration (FDA) has approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have had at least a partial response to previous multiagent, multimodality therapy including anti-GD2 immunotherapy.

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FDA Approval Dermatology Drugs DNA 52

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Pharma companies have begun to explore a host of novel digital endpoints that could have far-reaching implications for accelerating drug development and adoption.

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Clinical Trials Clinical Trials Trials Regulation 100

XTalks

OCTOBER 31, 2024

With De Novo US Food and Drug Administration (FDA) authorization in 2024, it’s the first tool of its kind to integrate such a broad biomarker panel for sepsis detection. As the first AI-driven tool for skin cancer detection at the point of care, it enhances dermatology practice efficiency and patient safety.

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The Pharma Data

AUGUST 22, 2021

Opdivo is now approved in earlier stages of disease for three types of cancer, including the first and only PD-1 inhibitor approved for urothelial carcinoma in the adjuvant setting. today announced that Opdivo ® (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S.

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pharmaphorum

OCTOBER 26, 2022

Food and Drug Administration approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist and the first FDA-approved steroid-free topical medication in its class. Two months later, Arcutis won approval for its Zoryve (roflumilast) cream. First in class. In May, the U.S. Side effects, front and centre.

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Hormones FDA Approval Doctor Doctors 98

The Pharma Data

APRIL 6, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

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Drugs Dermatology Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 24, 2024

In a major development for those battling moderate-to-severe atopic dermatitis, the US Food and Drug Administration (FDA) approved Eli Lilly’s Ebglyss (lebrikizumab-lbkz). The FDA approval is based on data gathered in three pivotal Phase III clinical trials: ADvocate 1, ADvocate 2 and ADhere.

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Clinical Trials Clinical Trials FDA Approval Trials 52