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FDA Approves ARMLUPEG (Pegfilgrastim-unne) Biosimilar

The FDA has approved ARMLUPEG (pegfilgrastim-unne), a biosimilar drug manufactured by LUPIN LTD. This approval marks the addition of a new biosimilar product to the market, following the FDA's review process.

FDA Approval of JUBEREQ and OSVYRTI (denosumab-desu)

The FDA has approved Biologic License Application (BLA) 761424 for JUBEREQ and OSVYRTI, both containing the active ingredient denosumab-desu, submitted by ACCORD BIOPHARMA INC. This approval marks the addition of new prescription injectable medications to the market.

FDA Approves Ranibizumab-leyk Biosimilar (NUFYMCO)

The FDA has approved the Biologic License Application (BLA) 761473 for NUFYMCO (ranibizumab-leyk) from FORMYCON AG. This approval marks the addition of a new biosimilar product to the market.

FDA Approves Filgrastim-LAHA Biosimilar

The FDA has approved FILKRI (filgrastim-LAHA), a biosimilar product, for ACCORD BIOPHARMA INC. The approval was granted on January 15, 2026, under Biologic License Application (BLA) 761027. This marks the addition of a new biosimilar option to the market.

FDA Approves First Generic Florfenicol and Flunixin Injection

The FDA has approved nixiFLOR, the first generic version of florfenicol and flunixin meglumine injection for treating bovine respiratory disease. This approval marks a new generic option for beef and non-lactating dairy cattle, with a withdrawal period of 38 days.

FDA Issues Emergency Use Authorization for F10 Antiseptic Wound Spray for New World Screwworm

The FDA has issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide for the prevention and treatment of New World screwworm in multiple animal species, excluding domestic dogs and cats. This authorization allows for broader use than previously approved products, with specific food safety guidelines for treated animals.

FDA Authorizes Drugs for New World Screwworm in Dogs and Cats

The FDA has issued two Emergency Use Authorizations (EUAs) for NexGard and NexGard COMBO for the treatment of New World screwworm infestations in dogs and cats, respectively. These EUAs are effective until the HHS Secretary terminates the public health emergency declaration for this pest.

FDA Guidance on Defining Drug Use Durations for Medically Important Antimicrobials

The FDA has finalized guidance (GFI #273) recommending how animal drug sponsors can voluntarily establish defined durations of use for medically important antimicrobial drugs administered in feed to food-producing animals. Over 100 drugs are affected, and sponsors are expected to submit revised labeling within approximately three years.

FDA Issues Emergency Use Authorization for Ivomec to Prevent Screwworm in Cattle

The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution to prevent New World screwworm infestations in cattle. This authorization allows for over-the-counter use under specific conditions and is effective until the declared emergency is terminated.

FDA Notification: Safety Labeling Change for Influenza Vaccine

The FDA has notified GlaxoSmithKline Biologicals of a required safety labeling change for its FLUARIX influenza vaccine. Postmarketing studies indicate an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination.