Press Releases
Press Releases
U.S. FDA Approves CSL Behring’s AFSTYL for adults and children with haemophilia A
CSL announced that the US Food and Drug Administration (FDA) has approved AFSTYLA® , CSL Behring’s novel long-lasting recombinant factor VIII single-chain therapy for adults and children with haemophilia A. AFSTYLA is indicated in adults and...
Press Releases
Daiichi Sankyo Launches Antiplatelet Agent Efient® Tablets 20mg
Daiichi Sankyo Company, Limited announced that it has launched the antiplatelet agent Efient® Tablets 20mg (JAN: Prasugrel Hydrochloride; approval to market: January 20, 2016; NHI drug price listing: May 25, 2016) in Japan. Efient® is an...
Press Releases
EISAI To Launch In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate) As Adjunctive Therapy For Partial-Onset And Generalized Tonic-Clonic Seizures In Japan
Eisai Co Ltd announced that it will launch its in-house-discovered antiepileptic drug (AED) Fycompa® Tablets 2 mg and 4 mg (perampanel hydrate) as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures). or primary...
Press Releases
Novartis highlights its strong foundation for long-term, sustainable growth at the third Meet Novartis Management event
Outlines actions underway to accelerate launch of Entresto®, including further expansion of US primary care field force, and reinforce strong uptake of Cosentyx® Highlights leading pipeline of second generation immuno-oncology assets. Confirms Sandoz on track for...
Press Releases
FDA Recommends Approval Of Sanofi Treatment For Adults With Type 2 Diabetes
Sanofi announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. FDA recommended the approval of the NDA for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the...
Press Releases
GSK, Fondazione Telethon and Ospedale San Raffaele announce publication of pivotal safety and efficacy of gene therapy for children with ADA-SCID
GSK, Fondazione Telethon and Ospedale San Raffaeletoday announced the publication in BLOOD of the long-term safety and efficacy data from an analysis of 18 children with ADA-SCID treated. with hematopoietic stem cell gene therapy between 2000...
Press Releases
Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%
Allergan plc announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S....
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