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Krystal Biotech to Present at Guggenheim 6th Annual Biotechnology Conference
2/1/2024
Krystal Biotech, Inc. today announced that the Company will participate in the Guggenheim 6th Annual Biotechnology Conference, which takes place in New York on February 7-8.
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European Commission Approves KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
1/10/2024
Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced that the European Commission (EC) granted conditional marketing authorization for KRAZATI ® ( adagrasib ) as a targeted treatment option for adult patients with KRAS G12C.
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Krystal Biotech Receives Permanent J-code (J3401) for VYJUVEK®
1/4/2024
Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J3401) for VYJUVEK® (beremagene geperpavec-svdt), the first U.S. Food and Drug Administration-approved treatment for dystrophic epidermolysis bullosa (DEB).
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Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.
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Krystal Biotech Receives Orphan Drug Designation from the Japanese MHLW for Beremagene Geperpavec-svdt (B-VEC)
12/19/2023
Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).
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Neumora Therapeutics Announces NMRA-266 IND Clearance and Initiation of Phase 1 Clinical Study
11/27/2023
Neumora Therapeutics, Inc. today announced the initiation of a Phase 1 single ascending dose / multiple ascending dose study evaluating NMRA-266 in healthy adult participants.
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Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa
11/27/2023
Krystal Biotech, Inc. today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.
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Mirati Therapeutics Receives Positive Opinion from CHMP for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation Following a Re-Examination Procedure
11/10/2023
Mirati Therapeutics, Inc. today announced that following a re-examination procedure, the Company has received a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on KRAZATI ®.
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Krystal Biotech to Present at the Stifel 2023 Healthcare Conference
11/9/2023
Krystal Biotech, Inc. announced that the Company will participate in the Stifel 2023 Healthcare Conference in New York.
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Mirati Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Updates
11/6/2023
Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate updates.
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Krystal Biotech Announces Third Quarter 2023 Financial Results and Provides Business Update
11/6/2023
Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today reported financial results and key business updates for the third quarter ended September 30, 2023.
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Mirati Therapeutics Receives Approval from the MHRA for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
11/3/2023
Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI®.
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Krystal Biotech to Report Third Quarter 2023 Financial Results on November 6, 2023
10/30/2023
Krystal Biotech, Inc. will report its third quarter 2023 financial results on Monday, November 6, 2023, prior to the open of U.S. markets.
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The abstracts, made available Tuesday ahead of the European Society for Medical Oncology Congress 2023, show strong efficacy data from some promising non-small cell lung cancer treatments.
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Mirati Presents Late-Breaking Results Evaluating the Combination of Adagrasib and Pembrolizumab in First-Line Non-Small Cell Lung Cancer (NSCLC)
10/17/2023
Mirati Therapeutics, Inc.® (NASDAQ: MRTX) today announced updated results from the KRYSTAL-7 Phase 2 study evaluating adagrasib combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation at the European Society of Medical Oncology Congress (ESMO) 2023.
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Krystal Biotech to Present at the Chardan 7th Annual Genetic Medicines Conference
9/28/2023
Krystal Biotech, Inc. announced that the Company will participate in the Chardan 7th Annual Genetic Medicines Conference in New York.
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FDAQRC Promotions Press Release
9/28/2023
FDA Quality and Regulatory Consultants (FDAQRC) is pleased to announce the promotion of six employees during the third quarter.
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Mirati To Present Updated Clinical Data at ESMO Congress 2023
9/27/2023
Mirati Therapeutics, Inc.® announced several presentations to be unveiled at the European Society of Medical Oncology Congress 2023 taking place October 20 to 24, 2023 in Madrid, Spain.
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Krystal Biotech Announces FDA Clearance of Investigational New Drug Application for KB408 for the Treatment of Type 1 Alpha-1 Antitrypsin Deficiency
9/21/2023
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).
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Beacon Biosignals Receives FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S
9/14/2023
Beacon Biosignals is thrilled to announce the milestone achievement of FDA 510(k) Clearance for the Dreem 3S, an advanced wearable headband with integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep.