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Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDAapproved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.
For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. a biotech company specializing in the development and commercialization of genetic medicines for rare diseases, announced FDAapproval for Vyjuvek for the treatment of DEB.
has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Another noteworthy contender is Novan Inc.’s
Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.
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. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life.
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.
Hidradenitis suppurativa affecting roughly 1% of the population is a chronic skin condition marked by painful boils and abscesses that can significantly disrupt daily life. Janus kinase one (JAK1) plays a central role in the signaling pathways of several inflammatory cytokines.
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.
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).
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.
In this episode, Ayesha talked about the FDAapproval 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).
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.
“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.
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.
Last summer, Verrica Pharmaceuticals’ topical Ycanth (cantharidin) received FDAapproval 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.
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 FDAapproval for atopic dermatitis paved the way for the 2022 FDAapproval for vitiligo.
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.
Maraoui said the company’s dermatology-focused sales force is “now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.” Journey Medical plans to make Emrosi available by early 2025 through dermatology clinics and pharmacies across the US.
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 FDAapproval is based on data gathered in three pivotal Phase III clinical trials: ADvocate 1, ADvocate 2 and ADhere.
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 FDAapproval in 2019. In June, it received expanded approval for ulcerative colitis.
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 – Lifesciences giant J&J acquired Momenta Pharmaceuticals in a $6.5
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.
Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDAapproval 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 FDAapproval.
In 2023, there were significant advancements and notable trends in the lifesciences. Xtalks compiled a list of its top lifescience news and trends of 2023, which provided readers with the latest developments, information and expert insights across lifescience industries, including pharma, biotech and medical device.
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.
RELATED: Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics – Xtalks LifeScience Podcast Ep. 134 How Does Letybo Work? Letybo is classified as an acetylcholine release inhibitor and neuromuscular blocking agent.
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.
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.
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.
The US Food and Drug Administration (FDA) has granted approval to Checkpoint Therapeutics PD-L1 inhibitor Unloxcyt (cosibelimab-ipdl) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients who cannot be cured with surgery or radiation therapy.
Since its FDAapproval in 2017, Regeneron and Sanofi’s Dupixent has been hailed as an innovative treatment for patients with atopic dermatitis, with industry experts describing it as “life-changing.” ” Over the years, Regeneron has expanded Dupixents approved uses, most notably into asthma.
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