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News List

Pharma bodies confirm signing NDAs for no-deal Brexit plans europeanpharmaceuticalreview
August 16, 2019
The DHSC has confirmed that several pharmaceutical industry bodies have agreed to NDAs regarding plans for a no-deal Brexit.
FDA new drug approvals up 11% in 2018 biospectrumasia
August 01, 2019
“PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2019 Edition” reveals that mega cap bio/pharma companies received 17 novel approvals in 2018
Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review drugs
May 17, 2019
Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review.
Rho Adds Regulatory Strategy and Submissions Biz contractpharma
December 12, 2018
Rho, a full-service CRO, has added a new Regulatory Strategy and Submissions business segment to support the planning, development and submission of marketing applications, including.