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Human Drugs

Biden Sets New Cancer Moonshot Goals

President Biden re-launches his Cancer Moonshot with new goals and activities, including a cancer cabinet with FDA and other agencies.

Human Drugs

OTC Drug Formal Meeting Guidance

FDA issues a draft guidance on policies and procedures for formal agency meetings with sponsors or requestors of OTC monograph drugs.

Attorneys See More Telehealth False Claims Cases

Two Hogan Lovells attorneys see an ongoing Department of Justice interest in telehealth fraud and electronic health records cases.

Human Drugs

Janssen Gets Expanded Label for HIV-treating Cabenuva

FDA approves a Janssen Pharmaceutical expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two months for treating HIV-...

Human Drugs

Clinical Hold on LogicBio Gene Therapy

FDA orders a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemi...

FDA General

FDA Names House Staffer Associate Commissioner

FDA names House Energy and Commerce Committee chief health advisor Kimberlee Trzeciak as the agencys associate commissioner for legislative affairs.

Medical Devices

Bone Solutions 510(k) Cleared for Mg Osteorevive

FDA clears a Bone Solutions 510(k) for its Mg Osteorevive, a magnesium-based injectable and moldable bone void filler indicated for posterolateral spi...

Human Drugs

Jazz Pharma sBLA for M/W/F Rylaze Dosing

Jazz Pharmaceuticals submits a supplemental BLA for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanth...

Human Drugs

Firm Selling Misbranded, Unapproved Drugs: FDA

FDA warns Scottsdale, AZ-based Applied Health Solutions that it is marketing unapproved and misbranded new drugs on its Web site.