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December 05, 2018
Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.
December 02, 2018
FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.
November 27, 2018
The agency has approved two new chemical entities, Daurismo (glasdegib) from Pfizer, and Vitrakvi (larotrectinib) from Loxo Oncology, for treating cancers.
November 20, 2018
GSK has filed for a sBLA to FDA for the expansion of the indication of Nucala to include paediatric patients between 6 and 11 years old.
November 16, 2018
The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.
November 15, 2018
The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.
November 12, 2018
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
November 08, 2018
The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
November 02, 2018
The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
October 30, 2018
The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).