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FDA General

Biden Meets with Potential FDA Head Califf

President Biden meets with potential FDA commissioner nominee Robert Califf in what may be the last step before an official announcement.

Federal Register

Regulatory Review Determined for Orions Nubeqa

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Orion Corp.s Nubeqa (darolutamide).

Federal Register

Comments Sought on Xenotransplantation Guideline

Federal Register notice: FDA seeks comments on an information collection extension entitled PHS Guideline on Infectious Disease Issues in Xenotranspla...

Biologics

FDA Denies Vaccine EUA Revocation Petition

FDA denies an Informed Consent Action Network petition asking it to revoke the EUAs for the Moderna and J&J Covid vaccines.

Human Drugs

Real-World Data Standards Guidance

FDA publishes a draft guidance on data standards for applicable drug submissions using real-world data.

Human Drugs

FDA Expanding Covid Work with Aetion

FDA expands its Covid-19 regulatory science work with Aetion.

Medical Devices

FDA OKs Luminopia One for Lazy Eye

FDA gives de novo premarket approval to Luminopia One to use a virtual reality headset to treat amblyopia, or lazy eye, in children ages 4-7.

Human Drugs

Clinical Hold on AZ Blood Cancer Drug

FDA puts a clinical hold on an AstraZeneca trial of an investigational blood cancer drug after heart concerns were reported in one patient.

Human Drugs

Merck Recalls 1 Lot of Cubicin

Merck recalls one lot of Cubicin (daptomycin for injection) 500mg for intravenous use due to a complaint being received about a piece of glass found i...

Biologics

Dupixent Approved as Asthma Add-on Maintenance

FDA approves Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) as an add-on maintenance treatment for certain patients aged six to 11 years w...