FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Hospira Recalls Injectable Vancomycin Due to Particulates

Hospira recalls one lot of injectable vancomycin HCl single-dose fliptop 1.5 g vials due to two visible glass particulates observed in a single vial.

latest-news-card-1
Human Drugs

Lupin Recalls 4 Quinapril Lots

FDA says Lupin recalled one lot of 20 mg Quinapril tablets and three lots of 40 mg tablets due to the potential presence of N-Nitroso-Quinapril, a nit...

latest-news-card-1
Animal Drugs

FDA Approves Zycosan for Horses with Osteoarthritis

FDA approves the first injectable pentosan product for use in horses with osteoarthritis.

latest-news-card-1
Medical Devices

Reverse Calif. Consumer Protection Regime: WLF

Washington Legal Foundation asks the Supreme Court to reverse a California appeals court decision that hit Ethicon with $300 million in civil penaltie...

Human Drugs

Genentechs Lunsumio OKd for Some Lymphomas

FDA gives accelerated approval to Genentechs Lunsumio to treat some forms of follicular lymphoma.

Human Drugs

FDA Approves Gileads Sunlenca for Some HIV Patients

FDA approves Gileads Sunlenca, the first in a new class of drugs to treat some HIV-1 patients.

latest-news-card-1
Human Drugs

REMS Document Technical Conformance Guide

FDA publishes a technical conformance guide for its guidance on the format and content of a REMS document.

latest-news-card-1
Medical Devices

Jet Medical, Other Companies, Pay $700,000 in Device Cases

Jet Medical and two related companies agree to pay $700,000 to resolve criminal and civil charges involving Jets distribution of unapproved medical de...

latest-news-card-1
Human Drugs

Checkpoint Therapeutics BLA for Skin Cancer

Checkpoint Therapeutics files a BLA for cosibelimab, an investigational anti-PD-L1 antibody for treating patients with metastatic cutaneous squamous c...

latest-news-card-1
Human Drugs

5 Observations on Glenmark FDA-483

FDA releases the form FDA-483 issued following an inspection at the Goa, India-based Glenmark Pharmaceuticals drug manufacturing facility.