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Maroc Maroc - HAEI.ORG - A La Une - 13/Dec 12:37

CSL Receives Positive CHMP Opinion for Garadacimab in HAE

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 [...]

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NVO Gets Positive CHMP Opinion in EU for Ozempic Expanded Use in CKD

zacks.com - 13/Dec 13:48

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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Astria announces positive final results from target enrollment in the ALPHA-STAR Phase 1b/2 trial of navenibart for HAE

haei.org - 11/Dec 08:27

Astria Therapeutics announces positive final results from target enrollment in the ALPHA-STAR Phase 1b/2 trial of navenibart for HAE Astra...

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GILD Obtains Positive CHMP Opinion for Liver Disease Drug

zacks.com - 16/Dec 18:40

The CHMP recommends the approval of Gilead's seladelpar in combination with ursodeoxycholic acid for the treatment of primary biliary cholangitis in...

Aurobindo Pharma arm CuraTeQ gets positive EMA opinion for biosimilar Zefylti

times of india - 16/Dec 16:41

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, received a positive CHMP opinion for its filgrastim biosimilar, Zefylti, intended to treat...

Aurobindo Pharma arm CuraTeQ gets positive EMA opinion for biosimilar Zefylti

times of india - 16/Dec 16:41

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, received a positive CHMP opinion for its filgrastim biosimilar, Zefylti, intended to treat...

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CHMP Endorses Merck's Kidney Cancer Drug for Two Indications

zacks.com - 16/Dec 15:57

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.

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Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta

drugs.com - 12/Dec 04:12

SAN FRANCISCO--(BUSINESS WIRE) December 12, 2024 -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received...

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Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta

drugs.com - 12/Dec 04:12

SAN FRANCISCO--(BUSINESS WIRE) December 12, 2024 -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received...

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GSK Gets CHMP Nod for Expanded Use of HIV Combo & Jemperli

zacks.com - 17/Dec 15:43

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.

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EMA Panel Endorses Lilly's Omvoh for Expanded Use in Crohn's Disease

zacks.com - 16/Dec 12:23

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...

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