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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.
Cenegermin Eye Drops Receive European Union Approval: The First Biotechnological Drug Resulting from en-cphi.cn
July 21, 2017
Behind the development of cenegermin are decades of Italian research, stemming from the studies of Rita Levi Montalcini, winner of the Nobel Prize in Medicine for the discovery of the nerve growth factor (NGF).
MoH&FW, DCG(I) grants approval to RMS Regrow for Chondron financialexpress
April 17, 2017
Chondron ACI is indicated for the treatment of cartilage defects of the joints
Perrigo Announces FDA Final Approval For Hydrocodone Bitartrate And Homatropine Methylbromide Oral S firstwordpharma
February 20, 2017
Perrigo Company plc (NYSE, TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per 5 mL.
Emergent BioSolutions Receives BioThrax Approval contractpharma
February 07, 2017
German Federal Ministry of Health approves the company’s Michigan facility for large-scale manufacturing.

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