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Human Drugs

CURE ID App Updated

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

Human Drugs

Progress Being Made in Lung Cancer Therapies: Analysis

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

Human Drugs

Mustang Bio Gets Orphan Status for CAR T Cell Therapy

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

Human Drugs

Senators Unveil Legislation to Help with Insulin Costs

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

Human Drugs

Concerns About Opioid Mail-Back Envelope Proposal

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

Medical Devices

BD Recalls Intraosseous Products

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

Human Drugs

Merarini Files NDA for Breast Cancer Therapy

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

Biologics

Updated CBER Guidance Agenda

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

Biologics

Krystal Biotech BLA for Topical Gene Therapy

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

Human Drugs

Florida Man Arrested in HIV Drug Distribution Scheme

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