Kye Pharmaceuticals announced it has submitted a New Drug Submission, or NDS, to Health Canada for the regulatory review and approval of ...

Kye Pharmaceuticals, Inc. ("Kye") announced today it has submitted a New Drug Submission (NDS) to Health Canada for the ...

Health Canada granted priority review to an application seeking approval of vamorolone, marketed in the U.S. as Agamree, for ...

Catalyst Pharmaceuticals (CPRX) reported that its sub-licensee in Canada, Kye Pharmaceuticals, has announced that Health Canada has accepted ...

Santhera's Duchenne muscular dystrophy (DMD) therapy Agamree has been cleared for NHS use after a confidential pricing agreement. The deal means that Agamree (vamorolone) will be available to ...

Dario Eklund, CEO of Santhera said: "The last 12 months have been a pivotal period for both the Company and DMD patients, as we began the global commercial roll-out of AGAMREE. Today, we are ...

AGAMREE, which is already approved and available in the United States, could become the first authorized DMD treatment in Canada if approved. The drug, a corticosteroid designed to maintain efficacy ...

(CNW Group/Kye Pharmaceuticals Inc.) "Muscular Dystrophy Canada (MDC) is pleased that Health Canada has granted Priority Review for AGAMREE ® (vamorolone). While corticosteroids have been a key ...

Dario Eklund, CEO of Santhera said : "The last 12 months have been a pivotal period for both the Company and DMD patients, as we began the global commercial roll-out of AGAMREE. Today, we are ...

Pratteln, Switzerland, March 24, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces that at its Capital Markets Day (CMD) in Zurich today, the Company will discuss the commercial progress with the ...