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Bankrupt Akorn Recalls All Products

[ Price : $8.95]

Akorn through its bankruptcy (Chapter 7) trustee recalls various within-expiry human and animal products because the company has c...

Vertex Gains Expanded Use for Cystic Fibrosis Drug

[ Price : $8.95]

FDA approves a Vertex Pharmaceuticals supplemental NDA for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor) to incl...

FDA Warning on Androgen Receptor Modulators

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FDA issues a warning about adverse event reports related to selective androgen receptor modulators (SARMs), which are often market...

Advisors Asked About Olaparib sNDA Population

[ Price : $8.95]

FDA asks the Oncologic Drugs Advisory Committee whether an sNDA for AstraZenecas prostate cancer drug olaparib in combination with...

FDA Lifts Warning Letter Against Medtronic

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FDA lifts a 2021 Warning Letter to Medtronic that followed an inspection of the companys diabetes headquarters in Northridge, CA. ...

QS, MDR, Other Violations in Medivance Inspection

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FDA warns London, UK-based Medivance Instruments about multiple violations in its manufacturing of the Velopex AquaCare line of de...

Medolife Illegally Selling Unapproved New Drugs: FDA

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FDA warns Burbank, CA-based Medolife Rx that it is illegally marketing several unapproved new homeopathic drug products.

Streamlined Cancer Trials Can Cause Discomfort: Singh

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FDA Oncology Division director Harpreet Singh cautions on discomfort that clinical investigators may feel about the agencys effort...

Biogen Accelerated Approval for ALS Drug

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FDA grants Biogen accelerated approval for Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis associated with...

FDA Lifts Hold on Maat Pharma Phase 3 Trial

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FDA lifts its clinical hold against a MaaT Pharma IND for an open-label, single arm Phase 3 pivotal clinical trial evaluating the ...