DUBLIN, Ireland, and Boston MA, June 23, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for ...

Credit: Krystal Biotech. Vyjuvek is a topical HSV-1 vector-based gene therapy. The Food and Drug Administration (FDA) has approved Vyjuvek ™ (beremagene geperpavec-svdt) for the treatment of wounds in ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued a complete response letter based on lack of information on certain manufacturing and release ...

The deficiencies noted in the CRL were not related to efficacy or safety data. The Food and Drug Administration (FDA) has issued a Complete Response Letter to Abeona Therapeutics regarding the ...

Recessive dystrophic epidermolysis bullosa, also called RDEB, is one form of epidermolysis bullosa. Epidermolysis bullosa is a rare genetic condition that causes very fragile skin. With RDEB, even a ...

BOSTON and MIAMI, Oct. 1, 2020 /PRNewswire/ -- Aegle Therapeutics Corporation today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AGLE-102™ for the ...

PITTSBURGH, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today welcomed the European Medicines Agency's (EMA’s) ...

Beremagene geperpavec-svdt (B-VEC) entered the market in 2023 as the first approved corrective treatment for dystrophic epidermolysis bullosa (DEB), a rare genetic disease affecting the skin and nails ...

Approval allows for dosing at home or in a healthcare setting, as well as patient or caregiver administration if deemed appropriate by a healthcare professional VYJUVEK was approved by the FDA in the ...

Please provide your email address to receive an email when new articles are posted on . Recessive dystrophic epidermolysis bullosa is a rare and serious condition. Zevaskyn is the first FDA-approved ...