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January 30, 2026 09:47 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) in the EU

Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion following re-examination, which will be reviewed by the European Commission (EC), with a decision anticipated by March...
January 30, 2026 09:47 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) in the EU

Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion following re-examination, which will be reviewed by the European Commission (EC), with a decision anticipated by March...
January 30, 2026 09:47 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of 2mg/kg Body Weight Every-Four-Weeks for Elfabrio® (pegunigalsidase alfa) ▼ in the EU

Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion following re-examination, which will be reviewed by the European Commission (EC), with a decision anticipated by March...
December 16, 2025 08:30 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases Announces Health Canada Approval of Elfabrio® (pegunigalsidase alfa) for Fabry Disease

PARMA, Italy and WOODBRIDGE, Ontario, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for...
November 03, 2025 16:30 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU

PARMA, Italy and CARMIEL, Israel, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), have...
October 17, 2025 06:58 ET | Source: Chiesi Global Rare Diseases; Protalix Biotherapeutics

Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU

PARMA, Italy and CARMIEL, Israel, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for...
September 22, 2025 08:00 ET | Source: Chiesi Global Rare Diseases

Idebenone Accepted by FDA for Priority Review for Leber Hereditary Optic Neuropathy (LHON)

FDA grants Priority Review to idebenone for Leber Hereditary Optic Neuropathy (LHON), a disease for which there are no existing approved treatments in the U.S.; action date of February 28, 2026 ...
September 09, 2025 11:00 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases Highlights Continued Commitment to Rare Disease Community at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025

Results presented focus on clinical insights on Fabry disease and alpha-mannosidosis Additional presentations showcase patient-reported journeys and outcomes PARMA, Italy, Sept. 09, 2025 (GLOBE...
September 09, 2025 11:00 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases Highlights Continued Commitment to Rare Disease Community at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025

Results presented focus on clinical insights on Fabry disease and alpha-mannosidosis Additional presentations showcase patient-reported journeys and outcomes PARMA, Italy, Sept. 09, 2025 (GLOBE...
July 28, 2025 08:00 ET | Source: Chiesi Global Rare Diseases

Chiesi Global Rare Diseases Spotlights the Profound Impact of Epidermolysis Bullosa in the Film “Living Between Pain and Hope” as part of “The Next Frontier,” a New Series Presented by the Biotechnology Innovation Organization

BOSTON, July 28, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases (Chiesi) proudly shares its contribution to the thought-provoking film "Living Between Pain and Hope," as part of “The Next...