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US FDA approves generic versions of Novartis blockbuster MS treatment
expresspharma
December 09, 2019
The US Food and Drug Administration approved three generic versions of Swiss drugmaker Novartis AG’s top-selling multiple sclerosis (MS) medicine Gilenya.
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FDA approves generics of Novartis multiple sclerosis drug Gilenya
pharmaceutical-technology
December 09, 2019
The US Food and Drug Administration (FDA) has approved the first generic versions of Novartis multiple sclerosis drug Gilenya (fingolimod).
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Innovent Biologics Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements
En-CPhI.CN
December 03, 2019
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology ...
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FDA approves new treatment for adults with partial-onset seizures
fda
November 26, 2019
The U.S. Food and Drug Administration approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults.
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FDA approves novel treatment to target abnormality in sickle cell disease
fda
November 26, 2019
The U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.
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MC2 Therapeutics Announces FDA Acceptance of its New Drug Application for Wynzora™ Cream for Treatment of Plaque Psoriasis
b3cnewswire
November 26, 2019
MC2 Therapeutics, an emerging pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions ...
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Short Overview of FDA Regulations and Guidance for the Traditional Chinese Medicine (TCM)
Lin Zhang
October 15, 2019
Aabout 80% of the world still uses plants and plant-based products to treat medical conditions.
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WONTECH Receives FDA Clearance for 'HairBoom Air'
En-CPhI.CN
October 15, 2019
Reno Kim, CEO of WONTECH which a leading Korean laser and energy based medical aesthetic device company announced that its LLLT hair loss treatment device, HairBoom Air, received ...
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Novo Nordisk wins FDA green light for 'holy grail' diabetes drug Rybelsus
fiercepharma
September 26, 2019
Novo has not shared Rybelsus' list price, but the drug "will be competitively priced within the GLP-1 category," a company spokesman said by email.
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FDA approves oral semaglutide Rybelsus to treat type 2 diabetes
pharmaceutical-technology
September 26, 2019
FDA approval comes from results from ten PIONEER clinical trials conducted in a total of 9,543 adult type 2 diabetes patients.