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Lupin receives FDA approval for generic Atovaquone Oral Solution USP financialexpress
September 17, 2018
Lupin’s Atovaquone Oral Suspension USP, 750 mg/5 mL is the generic version of GlaxoSmithKline LLC’s Mepron Oral Suspension, 750 mg/5 mL
AstraZeneca gets further approval for Tagrisso in Japan pharmaphorum
August 22, 2018
AstraZeneca received approval from the Japanese regulator following a priority review of Tagrisso (osimertinib) as a first-line treatment of patients with positive non-small cell lung cancer (NSCLC), further expanding its currently authorised use in this
Pfizer announces EC approval of its oncology biosimilar biospectrumasia
August 06, 2018
The European Commission decision marks the approval of Pfizer’s first therapeutic oncology bio-similar.
FDA approves the first drug with an indication for treatment of smallpox europeanpharmaceuticalreview
July 19, 2018
The US Food and Drug Administration has approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox…
FDA approves Calcitriol’s new contract manufacturing submission biospectrumasia
July 18, 2018
This approval was necessary in order to market and commercialize Calcitriol in the United States.
FDA Expands Approval of Gilenya americanpharmaceuticalreview
May 18, 2018
The U.S. Food and Drug Administration (FDA) approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older.
New cancer immunotherapy drugs rapidly reach patients after approval europeanpharmaceuticalreview
May 15, 2018
The majority of patients eligible for cancer immunotherapy drugs known as checkpoint inhibitors received treatment within a few months of FDA approval, according to a new Yale-led study.
Daiichi Sankyo seeks approval for Diagnogreen biospectrumasia
February 26, 2018
Daiichi Sankyo Submits Application for Additional Indication and Dosage for DiagnogreenⓇ for Injection 25 mg in Japan
Current Situation of Biosimilars in China III: Analysis of Biosimilars of Five Blockbust Tang
December 27, 2017
The biosimilars in China just started, and the biosimilar review and approval policies continue to be improved.
FDA Expands Approval of Sprycel americanpharmaceuticacreview
November 13, 2017
As part of its commitment to children and adolescents with cancer, Bristol-Myers Squibb continues to explore pediatric applications for investigational oncology agents within its broad development program.

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