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Guide on Viral Transport Media Enforcement

[ Price : $8.95]

FDA posts a final guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health...

Positive Data on AstraZeneca Covid-19 Vaccine Trial

[ Price : $8.95]

AstraZeneca reports positive interim data from an the ongoing Phase 1-2 COV001 trial, which showed that its AZD1222 vaccine was to...

Hearing Notice Canceled on Carbadox Withdrawal

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Federal Register notice: FDA withdraws a notice of opportunity for a hearing that proposed to withdraw the approved uses of carbad...

Proposed Order to Revoke Carbadox Approval

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Federal Register notice: FDA proposes an order to revoke the approved method for detecting residues of carbadox, a carcinogenic ne...

FDA Science Advisors to Get Agency Tox Research Updates

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Federal Register notice: FDA announces an 8/18-19 Science Advisory Board to the National Center for Toxicological Research meeting...

Guide on Real-world Data in Animal Drug Filings

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Federal Register notice: FDA makes available a draft guidance entitled Use of Real-World Data and Real-World Evidence to Support E...

Lilly Latruvo BLA Approval Revoked

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Federal Register notice: FDA announces it is revoking approval of an Eli Lilly BLA for Lartruvo (olaratumab), indicated for combin...

Warning Sent to Web Site on Unapproved Drugs

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FDA sends a Warning Letter to the operators of www.pharmaboosters.com over marketing unapproved and misbranded drugs.

FDA Clears Ambu Single-use Duodenoscope

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FDA clears an Ambu 510(k) for its Ambu aScope Duodeno, a single-use duodenoscope.

Denovo Bio Fast Track for Enzastaurin

[ Price : $8.95]

FDA grants Denovo Biopharma a fast track designation for DB102 (enzastaurin) and its use as a potential treatment for patients wit...