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Positive Opinion

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Pfizer
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-086Apr 29, 2019
Autologous Gene Therapy Receives Positive Opinion from EMA Committee
Positive Opinion

Autologous Gene Therapy Receives Positive Opinion from EMA Committee

Emilie Branch

Pharma's Almanac

PAO-M04-19-NI-005Apr 02, 2019
BioMarin
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-008Mar 04, 2019
Amgen
Positive Opinion

Amgen Receives CHMP Positive Opinion To Expand Use Of BLINCYTO® (Blinatumomab)

Amgen

PR-M11-18-NI-74Nov 23, 2018
Trovagene
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-032Aug 09, 2018
Merck & Co.
EMA

European Medicines Agency Adopts Positive Opinion for KEYTRUDA®(pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy

Merck & Co.

PR-M08-18-NI-009Aug 02, 2018
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