Found 169 articles
Krystal Biotech, Inc. announced that the Company will participate in the Chardan 7th Annual Genetic Medicines Conference in New York.
Krystal Biotech Announces FDA Clearance of Investigational New Drug Application for KB408 for the Treatment of Type 1 Alpha-1 Antitrypsin Deficiency
Krystal Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug Application (IND) for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).
Dotmatics Releases Powerful Enhancements to its Biology Solution to Help Accelerate the Research and Discovery of Life-Improving Therapies
Dotmatics today announced the availability of the latest version of its Biology Solution, an end-to-end biologics data management and analysis tool designed to help R&D leaders get more insight from their data, faster.
Krystal Biotech Announces Orphan Drug Designation Granted to KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
Krystal Biotech, Inc. announced that the U.S. Food and Drug Administration granted Orphan Drug Designation for KB408 for the treatment of alpha-1 antitrypsin deficiency.
Krystal Biotech, Inc. announced that it has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million.
Krystal Biotech, Inc. reported financial results and key operational progress updates for the second quarter ended June 30, 2023.
Allakos Inc. announced the appointment of Rand Sutherland, M.D. and Dolca Thomas, M.D. to the Allakos board of directors.
Krystal Biotech Announces Pipeline Expansion into Oncology and FDA Acceptance of IND Application for Lead Oncology Candidate KB707
Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that it has expanded its R&D pipeline to oncology and that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application of its lead oncology drug candidate KB707 for the treatment of locally advanced or metastatic solid tumor malignancies.
Arbutus Biopharma Corporation announced the appointment of Dr. Karen Sims as Chief Medical Officer and Mr. Christopher Naftzger as General Counsel and Chief Compliance Officer.
Sight Sciences, Inc. announces that Catherine Mazzacco was elected to the Company’s board of directors at its Annual Meeting of Stockholders held on June 8, 2023.
Krystal Biotech, Inc. a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, announced that the Company will participate in the following upcoming investor conferences.
FDA Approves Groundbreaking New Product Utilizing Berkshire Sterile Excipient Gel to Treat 'Butterfly Children'
On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy approved to treat dystrophic epidermolysis bullosa (DEB) in children and adults six months of age or older.
Orsini Specialty Pharmacy Selected as part of the Limited Specialty Pharmacy Network For VYJUVEK™, the First Gene Therapy for the Treatment of Dystrophic Epidermolysis Bullosa
Orsini Specialty Pharmacy announced that Krystal Biotech has selected it as part of the limited specialty pharmacy network for VYJUVEK™, a topical gene therapy for the treatment of Dystrophic Epidermolysis Bullosa.
The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.
Krystal Biotech, Inc. today announced that it has entered into a securities purchase agreement for the sale of 1,729,729 shares of its common stock at $92.50 per share in a private placement (the PIPE) to certain qualified institutional buyers.
Landmark victory for individuals living with DEB and their families, the FDA announced their approval of Krystal Biotech’s VYJUVEK™ for the treatment of Dystrophic Epidermolysis Bullosa (DEB).
400 million people around the world are affected by a rare disease. 95% of rare diseases lack an FDA approved treatment or cure.
Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEK™ (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa
Krystal Biotech, Inc. (the Company) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today announced the US Food and Drug Administration (FDA) has approved VYJUVEK™ (beremagene geperpavec-svdt) for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa (DEB).
FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa
Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
The FDA has four events lined up this week, including a target action date for Krystal Biotech's gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
Krystal Biotech, Inc. today reported financial results and key operational progress updates for the first quarter ended March 31, 2023.