XTalks

JANUARY 2, 2024

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 FDA approval for Vyjuvek for the treatment of DEB.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

XTalks

MAY 31, 2022

The precise cause of psoriasis is unknown, but risk factors include genetics and a family history of the condition, heavy alcohol consumption, stress, smoking and dry or cold weather. 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

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). As a topical treatment, it is also the first readily redosable gene therapy.

Gene Therapy 97

Gene Therapy Gene FDA Approval Dermatology 97

FDA Law Blog

NOVEMBER 10, 2024

Interestingly, based on a review of the 709 Orphan Products Clinical Trials Grants awarded since 1983 that are listed in FDA’s public database , as of October 1, 2024, only 48 Phase 3 trials have been granted an award (eight of which were Phase 2/3 trials). Relative to other areas of medicine (e.g.,

Production 69

Production Clinical Development Development Regulation 69

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. It leads to partial or complete hair loss on the scalp and other body parts, with patterns varying from patchy bald spots to total scalp or body hair loss.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

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

AUGUST 7, 2024

The exact cause of psoriasis remains unclear, but it is believed to involve a combination of genetic and environmental factors. This includes Bristol Myers Squibb’s Sotyktu (deucravacitinib), which received US Food and Drug Administration (FDA) approval in 2022. In June, it received expanded approval for ulcerative colitis.

FDA Approval 52

FDA Approval Genetics Antibody Drugs 52