Orbicular’s Ozempic generic gets U.S. FDA tentative nod
The product will be marketed and commercialised in the U.S. by Apotex, which is the ANDA applicant, complex peptide-based generics ...
Tag: FDA
Despite Concerns Over Breast Screening, FDA OKs New Use for Dermal Filler
(MedPage Today) -- The FDA approved a subdermal implant (Radiesse) for filling wrinkles and providing volume in the so-called décolleté ...
FDA Approves First Farxiga Generics for Type 2 Diabetes
(MedPage Today) -- The FDA approved the first generics of dapagliflozin (Farxiga) tablets for adults with type 2 diabetes, the ...
Garlic Recall Over Botulism Risk; FDA Warns on Supplement; Urban Smells and Insomnia
(MedPage Today) -- Note that some links may require registration or subscription. Certain lots of Christopher Ranch and Garland-branded peeled ...
Raw Dairy Farm Recalls Cheese Products as FDA Investigates E. Coli Outbreak
(MedPage Today) -- A California dairy producer that health authorities have been investigating amid an ongoing outbreak of E. coli ...
FDA Warns of Fatal Liver Injuries Tied to Drug It Wants Pulled From Market
(MedPage Today) -- The FDA on Tuesday warned that postmarketing data has turned up dozens of serious cases of drug-induced ...
Supplement Makers Push FDA to Allow Peptides and Other New Ingredients
(MedPage Today) -- Makers of dietary supplements are pushing the FDA to expand the types of ingredients they can put ...
FDA Warns of Seizure Risk With Some Parkinson’s Drugs
(MedPage Today) -- The FDA issued a safety communication today warning of a potential increased risk of seizures tied to ...
FDA OKs First Drug for Liver Disease-Related Pruritus
(MedPage Today) -- The FDA approved linerixibat (Lynavoy) as the first drug indicated for cholestatic pruritus stemming from primary biliary ...
High-Dose Wegovy Wins FDA Approval
(MedPage Today) -- The FDA approved a higher dose of the GLP-1 receptor agonist semaglutide for weight loss, dubbed Wegovy ...