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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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.

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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

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.

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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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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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XTalks

MAY 31, 2022

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

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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. Skin-related diseases are more than skin deep.

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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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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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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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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. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.)

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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

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.

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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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pharmaphorum

MAY 18, 2021

It’s the same active ingredient that is used in Incyte/Novartis Jakafi/Jakavi, which is FDA approved in oral form for myelofibrosis, polycythemia vera and graft-versus-host-disease.

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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. 52-week data is expected in the coming weeks. billion in this indication alone.

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The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) approval of Dupixent in September 2022 and the European Medicines Agency approval of Dupixent in December 2022. Dupixent is the only approved biologic indicated for prurigo nodularis in the U.S. Results from the trials were the basis for the U.S. Gil Yosipovitch, M.D.

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XTalks

AUGUST 7, 2023

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

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XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. Check out this article to learn about the biotech companies that went public this year.

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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. Otezla – which Amgen acquired for $13.4

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The Pharma Data

MARCH 27, 2022

Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. associate professor of dermatology at Yale School of Medicine and lead author of these analyses. “In 2022, OLUMIANT could become the first medicine ever approved to treat adults with alopecia areata.

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pharmaphorum

DECEMBER 1, 2021

Last year, the FDA approved a new topical hormonal therapy – Cassiopea’s androgen receptor inhibitor Winlevi (clascoterone) – which became the first new drug for acne in nearly 40 years. Oral isotretinoin can also be effective but is associated with serious side effects so is generally a last-line option.

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pharmaphorum

JULY 19, 2022

The FDA has been paying close attention to the safety of JAK inhibitors, and Opzelura was approved with black box warning that includes JAK class-wide wording for risks such as infections, heart-related events and cancer, despite being used on the skin rather than administered systemically.

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pharmaphorum

FEBRUARY 28, 2022

There are currently no FDA-approved treatment options for EB, a rare group of inherited disorders characterised by extremely fragile skin that blisters and tears from even minor friction or trauma.

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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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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 Dermatologic Adverse Reactions 7. of patients.

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The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

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Roots Analysis

JANUARY 3, 2024

However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002. Afterwards, in 2003, the FDA approved Hyaluronic Acid Fillers (HA dermal fillers), bringing the much-anticipated innovation to all types of face and non-face augmentation products.

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The Pharma Data

AUGUST 22, 2021

3 “Nivolumab provides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate -274, and has the potential to become a new standard of care option in this setting.” Galsky,* M.D., 1 Please see Important Safety Information below.

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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. Both are once-a-day treatments.

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The Pharma Data

DECEMBER 30, 2020

When the deal was struck, J&J said nipocalimab provides the company with an opportunity to reach more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology.

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The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” EASI=Eczema Area and Severity Index, EASI-75=75 percent reduction in EASI from baseline to Week 16.

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pharmaphorum

SEPTEMBER 22, 2021

European regulators have also already approved Olumiant and Rinvoq for the inflammatory skin disorder. Incyte’s JAK1/2 inhibitor is a new formulation of ruxolitinib, which has been available in oral form as Jakafi for a decade as a treatment for bone marrow cancer.

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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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The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. About Lilly in Dermatology. See the full Prescribing Information here. BA HCP ISI 09JUL2020. Skin-related diseases are more than skin deep.

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