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Vaccine Experts Fear Trump Pressure on Covid Tests: CNN

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CNN says vaccine experts it interviewed are concerned that the White House will pressure FDA to approve a coronavirus vaccine befo...

5 Companies Recall Some Metformin ER Drugs

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FDA identifies five companies that have recalled certain metformin extended-release products following agency testing showing leve...

Congressional Committees Set Appropriations Mark-Ups

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The Alliance for a Stronger FDA says congressional appropriations committees will be marking up bills for the FY 21 appropriations...

FDA Workload Likely to Increase Post-Pandemic: Officials

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CDER and CBER officials tell a BIO digital conference that they are working to cope with pent-up demand and clinical trial issues ...

FDA Approves Tivicay for Infants, Children with HIV

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FDA approves Viivs Tivicay and Tivicay PD for treating pediatric patients for HIV-1.

Comments Extended on Animal Bulk Compounding

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Federal Register notice: FDA extends until 10/15 the comment period related to a draft guidance for industry #256 entitled Compoun...

FDA Approves Mylans Semglee Insulin Glargine

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FDA approves Mylans Semglee insulin glargine product as a BLA.

IntelGenx Working on Rizaport NDA Resubmission

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IntelGenx says it learned in a 6/10 meeting with FDA officials about the CMC information that is needed in a resubmission of its R...

Lannett Sees Clear Path for Insulin Glargine Biosimilar

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Lannett says it is on track for a 2022 submission of a BLA for its insulin glargine biosimilar product.

Covid-19 Diagnostic Test Virtual Town Hall Set

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FDA schedules a 6/17 SARS-CoV-2 diagnostic test development and validation virtual town hall.