XTalks

MAY 31, 2022

At Dermavant, we are committed to advancing novel, patient-focused innovation in immuno-dermatology.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

OCTOBER 24, 2024

Amgen’s Otezla (apremilast) continues to expand its reach, with the US Food and Drug Administration (FDA) approving its use for children and adolescents with moderate to severe plaque psoriasis in 2024. Amgen also partnered with actor and entrepreneur La La Anthony to raise awareness about the impact of psoriasis on daily life.

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Research Dermatology Clinical Trials Clinical Trials 105

XTalks

JUNE 17, 2024

RELATED: Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics – Xtalks Life Science Podcast Ep. 134 How Does Letybo Work? Letybo is classified as an acetylcholine release inhibitor and neuromuscular blocking agent.

FDA Approval 52

FDA Approval Marketing Botox Clinical Trials 52

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. Dupixent inhibits signaling of both IL-4 and IL-13.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

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.

Filler 92

Filler FDA Approval Dermatology In-Vivo 92

XTalks

JUNE 26, 2024

The approval of Sofdra provides a much needed solution for individuals struggling with this socially and physically debilitating condition. Hyperhidrosis is the third most prevalent dermatological condition in the US, affecting roughly 15.3 million people, following acne and atopic dermatitis.

Clinical Trials 103

Clinical Trials Clinical Trials Dermatology FDA Approval 103

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).

Gene Therapy 97

Gene Therapy Gene FDA Approval Dermatology 97

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.

Clinical Trials 98

Clinical Trials Clinical Trials Dermatology Trials 98

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).

Gene Therapy 52

Gene Therapy Gene FDA Approval Life Science 52

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. This gives it a significant edge over a simple biosimilar designation.

FDA Approval 59

FDA Approval Production Dermatology Sales 59

XTalks

JULY 31, 2024

“An oral JAK that delivers proven results will be impactful for the alopecia areata community,” added Dr. Natasha Mesinkovska, associate professor and vice chair for Clinical Research of Dermatology, University of California, Irvine and investigator in the Leqselvi clinical development program.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

XTalks

JANUARY 12, 2024

Last summer, Verrica Pharmaceuticals’ topical Ycanth (cantharidin) received FDA approval as the first treatment for molluscum contagiosum. These lesions, which are skin colored to red are generally harmless but can cause significant discomfort as well as social stigma, particularly for younger patients.

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FDA Approval Trials Clinical Trials Clinical Trials 64

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.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Dermatology 52

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.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Containment 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.

FDA Approval 52

FDA Approval Dermatology Drugs DNA 52

pharmaphorum

JULY 8, 2022

Thread is helping customers create and utilise digital endpoints in therapeutic areas like dermatology, respiratory, and CNS applications where the voice data capture is becoming important. It needs to be performed with a benchmark, an FDA-approved device.”. About the author.

Clinical Trials 85

Clinical Trials Clinical Trials Trials Regulation 85

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.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

XTalks

AUGUST 7, 2024

This includes Bristol Myers Squibb’s Sotyktu (deucravacitinib), which received US Food and Drug Administration (FDA) approval in 2022. As a replacement, AbbVie had Skyrizi (risankizumab) waiting in the wings, which first received FDA approval in 2019. In June, it received expanded approval for ulcerative colitis.

FDA Approval 52

FDA Approval Genetics Antibody Drugs 52

The Pharma Data

DECEMBER 30, 2020

Andexxa, was approved by the U.S. Food and Drug Administration in 2018 and is currently the only approved Factor Xa inhibitor reversal agent. Johnson & Johnson Buys Up Momenta – Life sciences giant J&J acquired Momenta Pharmaceuticals in a $6.5

Antibody 52

Antibody Allergies Branding Dermatology 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

DECEMBER 20, 2023

In 2023, there were significant advancements and notable trends in the life sciences. Xtalks compiled a list of its top life science news and trends of 2023, which provided readers with the latest developments, information and expert insights across life science industries, including pharma, biotech and medical device.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

XTalks

AUGUST 14, 2024

In a press release video , Shawn Kwatra, MD, professor and chair of dermatology in the Department of Dermatology at the University of Maryland School of Medicine, explained that IL-31 is often referred to as the “master itch cytokine.” Dr. Kwatra noted that collectively, the disease has a severe impact on patients’ mental health.

Drug Delivery Systems 111

Drug Delivery Systems Dermatology Drug Delivery Antibody 111

XTalks

JUNE 10, 2024

Sotyktu (deucravacitinib) is a one-of-its-kind oral medication approved by the US Food and Drug Administration (FDA) indicated to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a sentiment that heavily resonates within the psoriasis community.

Immune Response 52

Immune Response Dermatology Clinical Trials Clinical Trials 52