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Potential for Astellas' new prostate cancer drug with EC approval

Today (April 24), Astellas Pharma Inc. revealed that XTANDITM (enzalutamide) has received a label extension from the European Commission, marking it as the inaugural and only novel hormone therapy endorsed for high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer (nmHSPC) treatment in the European Union (EU).
Comunidad Autonoma De Cataluna Antonio Alcaraz Ahsan Arozullah Naoki Okamura European Medicines Agency Committee For Medicinal Products Human Use

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Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU400—Modifier Gene Therapy for Broad Retinitis Pigmentosa Indication

MALVERN, Pa., April 10, 2024 -- Ocugen, Inc. , a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that the...
Shankar Musunuri Head Of Communications European Medicines Agency Exchange Commission Committee For Medicinal Products Human Use Ocugen Inc

IMI-supported treatment against drug-resistant bacteria receives positive opinion from EMA

The EMAโ€™s Committee for Medicinal Products for Human Use recommendation for marketing authorisation means we are one step closer to treating adult patients with complicated intra-abdominal and urinary tract infections and hospital-acquired pneumonias caused by Gram-negative bacteria.
Medtech Europe Catherine Brett Niklas Blomberg Programme Office Development Authority Innovative Medicines Initiative

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