Press Releases
Press Releases
Merck receives positive CHMP opinion for Zepatier in the EU
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment...
Press Releases
The EC grants the European marketing authorization to StrimvelisTM
GlaxoSmithKline (GSK), Fondazione Telethon (Telethon) and Ospedale San Raffaele (OSR) announced that the European Commission has approved Strimvelis, the first ex-vivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID (Severe Combined Immunodeficiency due...
Press Releases
Positive CHMP opinion in EU for saxa/dapa (saxagliptin and dapagliflozin) for adults with type-2 diabetes
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes....
Press Releases
European CHMP Adopts Positive Opinion for Gilead’s Epclusa for the Treatment of All Genotypes of Chronic Hepatitis C
Gilead Sciences Inc announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®. ...
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
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...
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