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Human Drugs

FDA OKs Esteve Pharmas Pain NDA

FDA approves an Esteve Pharmaceuticals NDA for Seglentis (celecoxib and tramadol hydrochloride) for treating acute pain in adults.

Biologics

CDC Panel Backs Covid Booster Vaccines

CDCs Advisory Committee for Immunization Practices votes to recommend accepting FDAs 10/20 amended emergency use authorizations for booster doses of b...

Medical Devices

FDA Denies Stryker Patient Transport Exemption

FDA denies a Stryker Medical petition seeking a premarket notification exemption for some powered patient transport devices.

Human Drugs

Bryant Ranch Recalls Mislabeled Methocarbamol

Bryant Ranch Prepack recalls one lot of methocarbamol 500mg tablets due to a mislabeling error.

Biologics

Senators Want More Covid Vaccine Data

Sens. Collins and Burr ask FDA and CDC to make more data available on Covid vaccine efficacy and breakthrough infections.

FDA General

FY 2021 Enforcement Stats Decimated by Covid

FDA updates its fiscal year (FY) 2021 FDA enforcement and compliance data, which show just how badly Covid-19 has decimated the agencys Warning Letter...

Medical Devices

Cook Medical Recalls Transseptal Needle

FDA says Cook Medical has recalled all unexpired lots of its transseptal needle and transseptal needle with catheter due to the presence of rust in or...

Biologics

FDA Allows More, Mixed Booster Vaccines

FDA authorizes Covid-19 vaccine booster doses for certain Moderna and Johnson & Johnson vaccinated individuals; it also authorizes available booster d...

Human Drugs

House Passes Drug Continuous Manufacturing Bill

The House passes Rep. Pallones bipartisan National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing legislation.

Human Drugs

Stealth Bio NDA Gets Refuse-to-File Letter

FDA sends Stealth BioTherapeutics a refuse to file letter on its NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome.