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Adamis Recalls 4 Lots of Symjepi

[ Price : $8.95]

FDA says Adamis Pharmaceuticals is recalling four lots of Symjepi injection due to a potential manufacturing defect that could pre...

Moderna to Seek EUA for Infant Covid Vax

[ Price : $8.95]

Moderna says it will seek FDA emergency use authorization for its Covid-19 vaccine in infants 6 months to under 6 years old.

QS Violations at Chinas Unimicro Medical Systems

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FDA warns Chinas Unimicro Medical Systems about multiple serious violations of Quality System regulations in its production of pne...

Vaccines Panel to Discuss Covid-19 Boosters

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Federal Register notice: FDA plans a 4/6 advisory committee meeting to discuss considerations for use of Covid19 vaccine booster d...

FDA Debars Irfanali Momin for 5 Years

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Federal Register notice: FDA debars Irfanali Nisarali Momin for five years from importing or offering for import any drug into the...

FDA Denies Belbuca Petition

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FDA denies a BioDelivery Sciences petition seeking agency actions to restrict follow-on products citing Belbuca as the reference-l...

AMA Outstanding Govt Service Award to CBERs Marks

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The American Medical Association bestows its Award for Outstanding Government Service on CBER director Peter Marks for his Covid-1...

Covid-19 EUA Device Listing

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Federal Register notice: FDA updates its current listing of medical devices that have received an Emergency Use Authorization duri...

Provention Bio Refiles BLA for Diabetes Therapy

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Provention Bio refiles its BLA for teplizumab for the delay of clinical Type 1 diabetes in at-risk individuals.

FDA Approves BMS Opdualag for Some Melanomas

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FDA approves Bristol-Myers Squibbs Opdualag to treat some adults and pediatric patients with melanoma.