EMA accepts GSK’s belantamab mafodotin application
The drug was also accepted for accelerated assessment by the EMA’s Committee for Human Medicinal Products (CHMP).
Read Moreby Anna Smith | Feb 3, 2020 | News | 0
The drug was also accepted for accelerated assessment by the EMA’s Committee for Human Medicinal Products (CHMP).
Read Moreby Anna Smith | Jan 15, 2020 | News | 0
The company expects a CHMP decision in the second half of 2020.
Read Moreby Anna Smith | May 29, 2019 | News | 0
The company recently announced positive data from two Phase II clinical studies, in which QVM149 was shown to be superior to the comparators.
Read Moreby Anna Smith | May 29, 2019 | News | 0
The drug is Prestige’s lead development candidate biosimilar to Roche’s Herceptin.
Read Moreby Anna Smith | May 28, 2019 | News | 0
The company is seeking conditional marketing authorisation (CMA) for patients with DMD who are not using glucocorticoids.
Read Moreby Selina McKee | Oct 12, 2018 | News | 0
European regulators have validated Rigel Pharmaceuticals’ application to market fostamatinib for adult chronic immune thrombocytopenia (ITP).
Read Moreby Selina McKee | Aug 28, 2018 | News | 0
Bayer has filed a marketing application in Europe seeking approval for larotrectinib as treatment for TRK fusion cancer.
Read Moreby Selina McKee | Oct 9, 2017 | News | 0
AstraZeneca has submitted the first marketing application in Europe for its immunotherapy Imfinzi, seeking approval for the drug’s use to treat a subset of patients with lung cancer.
Read Moreby Selina McKee | Aug 15, 2017 | News | 0
Shire has filed for approval of lifitegrast in Europe for dry eye disease in the hope of securing approval for the first treatment in a new class of drugs to address signs and symptoms of the condition.
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