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Positive Opinion
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Positive Opinion
Pfizer Receives Positive CHMP Opinion for TALZENNA®(talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer
PR-M04-19-NI-086
Positive Opinion
Autologous Gene Therapy Receives Positive Opinion from EMA Committee
PAO-M04-19-NI-005
Positive Opinion
BioMarin Receives Positive CHMP Opinion in Europe for Palynziq® (pegvaliase Injection) for Treatment of Patients with Phenylketonuria (PKU) Aged 16 and Older
PR-M03-19-NI-008
Positive Opinion
Amgen Receives CHMP Positive Opinion To Expand Use Of BLINCYTO® (Blinatumomab)
PR-M11-18-NI-74
Orphan Drug
Trovagene Receives Positive Opinion for Orphan Drug Designation in the European Union for PCM-075, Trovagene's Investigational Cancer Drug
PR-M08-18-NI-032
EMA
European Medicines Agency Adopts Positive Opinion for KEYTRUDA®(pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy
PR-M08-18-NI-009