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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
Pfizer
PR-M04-19-NI-086
Apr 29, 2019
Positive Opinion
Autologous Gene Therapy Receives Positive Opinion from EMA Committee
Emilie Branch
Pharma's Almanac
PAO-M04-19-NI-005
Apr 02, 2019
Positive Opinion
BioMarin Receives Positive CHMP Opinion in Europe for Palynziq® (pegvaliase Injection) for Treatment of Patients with Phenylketonuria (PKU) Aged 16 and Older
BioMarin
PR-M03-19-NI-008
Mar 04, 2019
Positive Opinion
Amgen Receives CHMP Positive Opinion To Expand Use Of BLINCYTO® (Blinatumomab)
Amgen
PR-M11-18-NI-74
Nov 23, 2018
Orphan Drug
Trovagene Receives Positive Opinion for Orphan Drug Designation in the European Union for PCM-075, Trovagene's Investigational Cancer Drug
Trovagene
PR-M08-18-NI-032
Aug 09, 2018
EMA
European Medicines Agency Adopts Positive Opinion for KEYTRUDA®(pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy
Merck & Co.
PR-M08-18-NI-009
Aug 02, 2018
