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QS, MDR Issues at Chinas Wickimed

[ Price : $8.95]

FDA warns Chinas Wickimed Medical Equipment Manufacturing Company about Quality System and Medical Device Reporting violations in ...

Priority Review for Tibsovo Supplemental NDA

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FDA accepts for priority review a Servier supplemental NDA for Tibsovo (ivosidenib tablets) as a potential treatment for patients ...

FDA Updates Covid-19 Guidance Listing

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Federal Register notice: FDA updates is listing of guidance documents related to the Covid19 public health emergency.

2 EUAs Revoked on Covid-19 Tests

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Federal Register notice: FDA revokes the Emergency Use Authorizations (EUAs) issued to Bio-Rad Laboratories for the BioPlex 2200SA...

Gileads Mixed Data on Trodelvy in Metastatic Breast Cancer

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A Phase 3 study evaluating Gileads Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2-metastatic breast cancer shows ...

FDA Partial Hold on Alpine Immune Cancer Trial

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FDA places a partial clinical hold on an Alpine Immune Sciences trial evaluating davoceticept in combination with pembrolizumab (M...

Pallone Introduces Bill to Revamp Accelerated Approvals

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House Energy and Commerce Committee chairman Frank Pallone (D-NJ) introduces the Accelerated Approval Integrity Act that would rev...

Speedy Approval for Opdivo in Lung Cancer

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FDA approves Bristol Myers Squibbs Opdivo (nivolumab) 360 mg (injection for intravenous use) five days after submitting an NDA for...

Merit Medical Breakthrough for Knee Embosphere Microspheres

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FDA grants Merit Medical Systems a breakthrough device designation for its Embosphere Microspheres for use in genicular artery emb...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 3/4/2022.