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CURE ID App Updated

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FDA and the National Center for Advancing Translational Sciences update the CURE ID crowd-sourcing drug repurposing app.

Progress Being Made in Lung Cancer Therapies: Analysis

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The LUNGevity Foundation says many lung cancer therapies are in development, including some relying on biomarkers.

Mustang Bio Gets Orphan Status for CAR T Cell Therapy

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FDA grants Mustang Bio an orphan drug designation for MB-106, a CD20-targeted, autologous CAR T cell therapy for treating Waldenst...

Senators Unveil Legislation to Help with Insulin Costs

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U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) reveal bipartisan legislation entitled Improving Needed Safeguards fo...

Concerns About Opioid Mail-Back Envelope Proposal

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Two drug stakeholder associations ask FDA to reconsider its proposal that opioid manufacturers provide mail-back envelopes to use ...

BD Recalls Intraosseous Products

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BD says it is recalling intraosseous products that have several issues.

Merarini Files NDA for Breast Cancer Therapy

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The Menarini Group submits an NDA for elacestrant and its use in patients with ER+/HER2 advanced or metastatic breast cancer.

Updated CBER Guidance Agenda

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CBER updates its guidance agenda for 2022 containing 18 guidances it plans to develop.

Krystal Biotech BLA for Topical Gene Therapy

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Krystal Biotech files a BLA for B-Vec (beremagene geperpavec), a topical gene therapy for treating patients with dystrophic epider...

Florida Man Arrested in HIV Drug Distribution Scheme

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The U.S. government arrests Lazaro Hernandez of Miami, FL, for allegedly distributing over $230 million in adulterated HIV drugs.