Novo Nordisk's diabetes drug, Ozempic, receives positive CHMP opinion in the EU for expanded use in T2D and CKD patients.
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CSL Receives Positive CHMP Opinion for Garadacimab in Hereditary Angioedema (HAE) CSL announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years [...]
Novo Nordisk's diabetes drug, Ozempic, receives positive CHMP opinion in the EU for expanded use in T2D and CKD patients.
Astria Therapeutics announces positive final results from target enrollment in the ALPHA-STAR Phase 1b/2 trial of navenibart for HAE Astra...
The CHMP recommends the approval of Gilead's seladelpar in combination with ursodeoxycholic acid for the treatment of primary biliary cholangitis in...
Aurobindo Pharma's subsidiary, CuraTeQ Biologics, received a positive CHMP opinion for its filgrastim biosimilar, Zefylti, intended to treat...
Aurobindo Pharma's subsidiary, CuraTeQ Biologics, received a positive CHMP opinion for its filgrastim biosimilar, Zefylti, intended to treat...
The CHMP's opinion is based on positive results from two late-stage studies on MRK's Welireg in two indications associated with renal cell carcinoma.
SAN FRANCISCO--(BUSINESS WIRE) December 12, 2024 -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received...
SAN FRANCISCO--(BUSINESS WIRE) December 12, 2024 -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received...
The CHMP recommends marketing approval to GSK's Vocabria plus JNJ's Rekambys for treating HIV-1 infection in adolescents aged 12 years and older.
The CHMP's opinion is based on late-stage data, which show that LLY's Omvoh is effective in Crohn's disease patients with or without prior biologic...