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FDA s new platform guidance aims to smooth regulatory encounters

FDA s new platform guidance aims to smooth regulatory encounters
fiercebiotech.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fiercebiotech.com Daily Mail and Mail on Sunday newspapers.

United statesPeter marksAmerican society of gene cell therapyDrug evaluationBiologics evaluationAmerican societyCell therapy

Gyre Pharmaceuticals Receives IND Approval from China s NMPA to Evaluate F230 for the Treatment of Pulmonary Arterial Hypertension

Gyre Pharmaceuticals Receives IND Approval from China s NMPA to Evaluate F230 for the Treatment of Pulmonary Arterial Hypertension
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China national medical products administrationDrug evaluationNational medical products administrationGyre pharmaceutical

Gyre Pharmaceuticals Receives IND Approval From China S NMPA To Evaluate F230 For The Treatment Of Pulmonary Arterial Hypertension

Gyre Pharmaceuticals Receives IND Approval From China S NMPA To Evaluate F230 For The Treatment Of Pulmonary Arterial Hypertension
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United statesSan diegoChan yingExchange commissionGyre through pharmaceuticalsGroup ltdChina national medical products administrationGyre pharmaceuticalsDrug evaluationNational medical products administrationGyre pharmaceuticalInvestigational new drugChief executive officerPrivate securities litigation reform actAnnual report

FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS

FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS
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Sarah yimOffice of therapeutic biologicsDrug administrationAmgen incAlexion pharmaceuticalsTherapeutic biologicsDrug evaluationBoxed warningRisk evaluationMitigation strategy

MIL-OSI USA: FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

Foreign Affairs Provides up to the minute Raw News, reportage, current affairs, Open Source Intelligence, OSI, Information, Analysis, and Essays, all published with immediacy at the time of relevancy

Sarah yimBkemv to amgen incHuman servicesDrug administrationUs department of healthOffice of therapeutic biologicsFor immediate releaseTherapeutic biologicsDrug evaluationBoxed warningBkemv risk evaluationMitigation strategy