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Eagle Pharmaceuticals : With QIDP, Eagle expects to receive eight or ten years of regulatory exclusivity upon NDA approval - Form 8-K

June 14, 2023

With QIDP, Eagle expects to receive eight or ten years of regulatory exclusivity upon NDA approval -- Company believes CAL02 is a new chemical entity , which would result in... | June 14, 2023

Lisam Wilson Eagle Pharmaceuticals Site Communications Inc Eagle Pharmaceuticals Inc Company Quarterly Reports On Form Investor Relations For Eagle Pharmaceuticals Inc

Source: marketscreener.com

Valneva Announces Publication Of Its Chikungunya Vaccine Candidate Phase 3 Data In The Lancet

June 13, 2023

English French

Instituto Butantan Juan Carlos Jaramillo Drug Administration European Union Horizon European Medicines Agency Health Canada

Source: menafn.com

RedHill Biopharma Announces Q1/2023 Financial Results and Operational Highlights

June 12, 2023

Q1/23 Talicia net revenues of $3.4 million; Cash balance of $28.8 million as of March 31, 2023[1]; Extinguishment of all debt obligations in exchange for the...

United States United Kingdom Redhill Biopharma Adi Frish Dror Ben Asher National Institutes Of Health

Source: prnewswire.com

Capivasertib in combination with FASLODEX® (fulvestrant) granted Priority Review in the US for patients with advanced HR-positive breast cancer

June 12, 2023

Decision based on CAPItello-291 Phase III trial results which showed the combination reduced the risk of disease progression or death by 40% vs. FASLODEX alone Potential first-in-class AKT... | June 12, 2023

United Kingdom United States San Antonio Daiichi Sankyo Susan Galbraith American Cancer Society

Source: marketscreener.com

FDA Panel Backs Traditional Approval of Lecanemab for Alzheimer Disease

June 12, 2023

An FDA committee voted unanimously that lecanemab-irmb (Leqembi) shows clinical benefit for the treatment of Alzheimer disease.

Drug Administration Central Nervous System Drugs Advisory Committee Priority Review Biologics License Application Clinical Dementia Rating Sum Scale Cognitive Subscale

Source: empr.com

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FDA Advisory Committee votes unanimously to confirm clinical benefit of LEQEMBI® (lecanemab-irmb) for the treatment of e

June 10, 2023

STOCKHOLM, June 10, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai...

South Korea Uppsala Lan United States Oskar Bosson Drug Administration Alzheimer Clinical Trial Consortium

Source: europapress.es

FDA Advisory Committee votes unanimously to confirm clinical benefit of LEQEMBI® (lecanemab-irmb) for the treatment of early Alzheimer's disease

June 10, 2023

/PRNewswire/ -- BioArctic ABs (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the U.S. Food and Drug Administrations (FDA) Peripheral...

Uppsala Lan United States South Korea Oskar Bosson National Institute On Drug Administration

Source: prnewswire.com

BioArctic: FDA Advisory Committee votes unanimously to confirm clinical benefit of LEQEMBI® (lecanemab-irmb) for the treatment of early Alzheimer's disease

June 10, 2023

STOCKHOLM, June 10, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the U.S. Food and Drug Administration's (FDA) Peripheral and Central

Uppsala Lan South Korea United States Oskar Bosson Health Canada On Ministry Of Health

Source: finanznachrichten.de

Vertex Pharmaceuticals Incorporated: FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

June 9, 2023

First CRISPR gene-editing filings to be accepted for review by FDA - FDA grants Priority Review for severe sickle cell disease (SCD) and Standard Review for transfusion-dependent beta thalassemia (TDT)

United States United Kingdom San Francisco Mecklenburg Vorpommern City Of Reshma Kewalramani

Source: finanznachrichten.de