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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Amicus Therapeutics Issues 2024 Environmental, Social, and Governance (ESG) Report
3/20/2024
Amicus Therapeutics, a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, issued its fourth annual Environmental, Social, and Governance report.
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Amicus Therapeutics to Present at Upcoming Investor Conferences in March 2024
3/1/2024
Amicus Therapeutics announced that management will participate in upcoming presentations at the following investor conferences in March.
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Amicus Therapeutics Announces Full-Year 2023 Financial Results and Corporate Updates
2/28/2024
Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the full-year ended December 31, 2023.
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Amicus Therapeutics to Announce Full Year 2023 Financial Results on February 28, 2024
2/15/2024
Amicus Therapeutics announced that the Company will host a conference call and live audio webcast on Wednesday, February 28, 2024, at 8:30 a.m. ET to discuss financial results for the full-year ended December 31, 2023.
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Amicus Therapeutics Receives the 2024 New Treatment Award for Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) at the 20th Annual WORLDSymposium™
2/8/2024
Amicus Therapeutics (Nasdaq: FOLD), today announced that WORLD Symposium™ has awarded Pombiliti™ ( cipaglucosidase alfa-atga ) + Opfolda™ ( miglustat ) the 2024 New Treatment Award, which recognizes important achievements in advancing treatments for lysosomal diseases which have attained regulatory approval.
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The first hearing on a potential injunction came the day before CMS is to release pricing proposals on 10 drugs.
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Amicus Therapeutics Announces Presentations and Posters at the 20th Annual WORLDSymposium™ 2024
2/1/2024
Amicus Therapeutics (Nasdaq: FOLD), today announced that one oral presentation and 11 posters across its development programs will be included at the 20th Annual WORLDSymposium™ 2024, being held February 4-9, 2024 in San Diego, CA.
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Mercalis Releases 2023 Annual Highlights
1/9/2024
Mercalis Inc. released its 2023 annual highlights, detailing the organization's impressive performance over the past year.
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Amicus Therapeutics Reports Preliminary 2023 Revenue and Provides 2024 Strategic Outlook
1/7/2024
Amicus Therapeutics, a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, provided its preliminary and unaudited 2023 revenue, corporate updates, and full-year 2024 outlook.
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Amicus Therapeutics to Present at the 42nd Annual J.P. Morgan Healthcare Conference
1/3/2024
Amicus Therapeutics announced that Bradley Campbell, President and Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 8, 2024, at 2:15 p.m. PT.
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Amicus Therapeutics Congratulates Executive Chairman John F. Crowley on Appointment as Next President and CEO of BIO
12/5/2023
Amicus Therapeutics (Nasdaq: FOLD) today announced that John F. Crowley, Executive Chairman of Amicus Therapeutics, will step down from the Amicus Board of Directors and assume the role of President and Chief Executive Officer of BIO, the Biotechnology Innovation Organization, effective March 4, 2024.
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Amicus Therapeutics Announces Third Quarter 2023 Financial Results and Corporate Updates
11/8/2023
Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the third quarter ended September 30, 2023.
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Amicus Therapeutics to Present at Upcoming Investor Conferences in November 2023
11/1/2023
Amicus Therapeutics announced that management will participate in upcoming presentations at the following investor conferences in November.
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Amicus Therapeutics to Announce Third Quarter 2023 Financial Results on November 8, 2023
10/27/2023
Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Wednesday, November 8, 2023, at 8:30 a.m. ET to discuss financial results for the third quarter ended September 30, 2023.
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Rodent Optic Nerve Head Wins the 49th Annual Nikon Small World Photo Microscopy Competition
10/17/2023
Nikon Instruments Inc. unveiled the winners of the 49th annual Nikon Small World Photomicrography Competition.
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Amicus Therapeutics Announces Presentation and Posters at World Muscle Society 2023
10/3/2023
Amicus Therapeutics (Nasdaq: FOLD), today announced that one oral presentation and four posters highlighting its development program for Pompe disease will be included at the 28th Annual Congress of the World Muscle Society (WMS) , being held October 3-7, 2023 in Charleston, SC.
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WuXi Biologics Congratulates Amicus Therapeutics on U.S. FDA Approval for New Treatment for Pompe Disease
10/2/2023
WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization, congratulates its strategic partner, Amicus Therapeutics, on receiving U.S. FDA's approval for Pombiliti™ + Opfolda™ 65mg capsules.
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Amicus Therapeutics and Blackstone Enter into $430 Million Strategic Financing Collaboration
10/2/2023
Amicus Therapeutics today announced that it has entered into a definitive agreement for a $430 million financing collaboration with funds managed by Blackstone Life Sciences and Blackstone Credit have agreed to provide Amicus with a $400 million senior secured term loan facilitating a refinancing of existing debt and a $30 million strategic investment in Amicus’s common stock.
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Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.