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Acadia sNDA for Dementia-related Hallucinations

[ Price : $8.95]

FDA accepts for review an Acadia Pharmaceuticals supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delu...

Pfizer, BioNTech Positive Data on Covid Vaccine Program

[ Price : $8.95]

Pfizer and BioNTech report positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccin...

FDA EUA for 1st Pooled Covid Test

[ Price : $8.95]

FDA reissues an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for pooled Covid-1...

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Verathon Recalls GlideScope Video Cable

[ Price : $8.95]

Verathon recalls the GlideScope Core One TouchSmart Cable due to the potential for temporary or complete loss of image when used w...

FDA Science Advisors to Get Agency Tox Research Updates

[ Price : $8.95]

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

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Use of Real-World Data and Real-World Evidence to Support E...