Infographic: Record year for ANDA approvals in US
The US FDA reached a record number of generic ANDAs last financial year, ending September 2018.
The US FDA reached a record number of generic ANDAs last financial year, ending September 2018.
Shire has filed a US FDA submission to manufacture plasma-volume replacement therapy, Flexbumin, at its new plant in Stanton Springs, Georgia.
MSD announced that the EMA’s CHMP has adopted a positive opinion recommending approval of Keytruda as an adjuvant therapy for the treatment of patients with melanoma.
The first MabThera biosimilar is expected to enter the US market in the first half of 2019, followed by Herceptin and Avastin versions in the second half of the year, says CEO.
CPhI Worldwide 2018
The company is considering an expansion beyond biosimilars into novel biologics development, says CEO TH Kim.