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Bayer’s new haemophilia A drug obtains FDA approval pharmaceutical-technology
September 03, 2018
Bayer has received approval from the US Food and Drug Administration (FDA) for its new haemophilia A drug Jivi (BAY94-9027) as routine prophylactic therapy in previously treated adults and adolescents aged 12 years and above.
FDA approves Roche’s cobas EGFR blood test as a companion diagnostic for AZ’s Iressa fiercebiotech
August 28, 2018
The FDA's OK follows companion diagnostic approvals in NSCLC for tyrosine kinase inhibitors Tarceva and Tagrisso. (Roche)
Eisai, Merck get FDA approval for LENVIMA capsules to treat HCC biospectrumasia
August 20, 2018
Marks second approval under Eisai-Merck global collaboration to co-develop and co-commercialize LENVIMA, following Japan in March 2018
Breast cancer device receives FDA approval cphi-online
August 08, 2018
The first non-radioactive, dual-tracer for sentinel lymph node biopsy approved in the US.
Amneal Announces FDA Approval, Launch of Generic Welchol americanpharmaceuticalreview
May 18, 2018
Amneal Pharmaceuticals announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol (colesevelam HCI) tablets, 625 mg.
Proteostasis Therapeutics receives FDA approval for Cystic Fibrosis drug biospectrumasia
March 19, 2018
The FDA Office of Orphan Products Development grants Orphan Drug Designation to novel drugs or biologics that are intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the United States.
FDA approves new insulin Fiasp® by Novo Nordisk pharmaasia
October 09, 2017
New fast-acting mealtime insulin Fiasp® by Novo Nordisk has been approved by the FDA for both type 1 and type 2 diabetes in adult patients.
Cycle Pharmaceuticals’ Ketorolac Tromethamine Injection receives FDA approval pharmaasia
September 25, 2017
FDA approval for the new Cycle Pharmaceuticals NSAID means the official go-ahead to launch the drug in the United States has been obtained.
Novartis granted first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019) Novartis
August 31, 2017
Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice.
Lupin receives FDA approval for Rosuvastatin Calcium tablets expressbpd
August 04, 2017
The medicine is indicated for the treatment of adult patients with hypertriglyceridemia

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