Found 297 articles
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.
Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the first quarter 2023 along with recent pipeline and corporate updates.
Krystal Biotech, Inc. today reported financial results and key operational progress updates for the first quarter ended March 31, 2023.
Journal of Clinical Oncology Publishes Rapid Communication Featuring Updated Clinical Data for Adagrasib as a Targeted Treatment for KRASG12C-Mutated Advanced Solid Tumors
Mirati Therapeutics, Inc.® (NASDAQ: MRTX) announced today the Journal of Clinical Oncology published in a Rapid Communication data indicating adagrasib, a potent and selective KRASG12C inhibitor, is well tolerated and demonstrates meaningful clinical activity in patients with pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), and other solid tumors harboring a KRASG12C mutation.
Krystal Biotech Announces Clinical Data on Topical Application of B-VEC to the Eye to Treat Ocular Complications in a Patient with Dystrophic Epidermolysis Bullosa Under a Compassionate Use Program
Krystal Biotech, Inc. announced today that the Company presented new data on the compassionate use of topical beremagene geperpavec (B-VEC) to treat a patient with dystrophic epidermolysis bullosa (DEB) with recurrent cicatrizing conjunctivitis at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting on April 23, 2023.
Krystal Biotech, Inc. announced today that the Company will be presenting new data on the compassionate use of topical beremagene geperpavec (B-VEC) to treat a patient with dystrophic epidermolysis bullosa (DEB) with recurrent cicatrizing conjunctivitis at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting being held from April 23-27, 2023 in New Orleans, LA.
Idorsia Files Petition with the Drug Enforcement Administration (DEA) Urging Them to De-Schedule Dual Orexin Receptor Antagonist Class of Insomnia Medications
Yesterday, a Citizen Petition (CP) was filed on behalf of Idorsia Pharmaceuticals (SIX: IDIA), urging the Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data.
Krystal Biotech, Inc. today announced the appointment of Catherine Mazzacco to its Board of Directors.
Krystal Biotech, Inc. announced today that the Company will participate in the 43rd Annual TD Cowen Health Care Conference, which is taking place in Boston from March 6-8.
Mirati Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates
Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the fourth quarter and full year of 2022 along with recent corporate updates.
Krystal Biotech Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress
Krystal Biotech, Inc. today reported financial results and key operational updates for the fourth quarter and year ending December 31, 2022.
Krystal Biotech Receives European Commission Orphan Designation for KB407 for the Treatment of Cystic Fibrosis
Krystal Biotech, Inc. announced today that the European Commission has granted orphan designation for KB407 for the treatment of Cystic Fibrosis (CF).
Krystal Biotech Announces FDA’s 3-Month Extension of BLA PDUFA Date and Regulatory Update for B-VEC to Treat Patients with Dystrophic Epidermolysis BullosaNEW PDUFA DATE OF MAY 19, 2023
Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that on January 5, 2023, the U.S. Food and Drug Administration (FDA) notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than April 20, 2023.
Mirati announces Adagrasib (KRAZATI™) Receives Breakthrough Therapy Designation from FDA for Patients with Advanced, KRAS-Mutated Colorectal Cancer and NEJM Publishes Phase 1b/2 Data from Adagrasib With or Without Cetuximab in Colorectal Cancer
Mirati Therapeutics, Inc. (NASDAQ: MRTX), announced today that the FDA has granted BTD to adagrasib in combination with cetuximab in patients with KRASG12C-mutated, advanced CRC whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.