FDA Approves Neuromodulation Device to Treat PTSD Symptoms
(MedPage Today) -- The FDA granted de novo approval for a neuromodulation device to treat symptoms associated with post-traumatic stress ...
Tag: FDA
FDA OKs First Treatment for Chronic Hepatitis D Infection
(MedPage Today) -- Chronic hepatitis delta virus (HDV) infection has its first FDA-approved treatment, after the agency granted accelerated approval ...
FDA Staff Blindsided by Move Allowing More E-Cigs, Nicotine Pouches Onto Market
(MedPage Today) -- Senior officials in the FDA's tobacco center were blindsided by a recent decision that opens the door ...
FDA Greenlights Novel Hypertension Pill for Tough-to-Treat Patients
(MedPage Today) -- The FDA approved the first-in-class oral aldosterone synthase inhibitor baxdrostat (Baxfendy) to treat adults with uncontrolled hypertension ...
FDA Wants Better Pregnancy Safety Data on Approved Drugs
(MedPage Today) -- The FDA on Friday issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs ...
FDA Expands Stelara Approval; Liver Cancer Blood Test; Pharmacotherapy for MASLD
(MedPage Today) -- The FDA expanded the approval of ustekinumab (Stelara) in Crohn's disease to include the treatment of kids ...
FDA Allows First Fruit-Flavored Vapes in Major Shift Under Trump
(MedPage Today) -- The FDA on Tuesday announced its first authorization of fruit-flavored electronic cigarettes intended for adult smokers, a ...
FDA Approves First Non-Antipsychotic Drug for Alzheimer’s Agitation
(MedPage Today) -- The FDA expanded the indication for dextromethorphan hydrobromide and bupropion hydrochloride (Auvelity) extended-release tablets to treat agitation ...
FDA Opens Early Access to Novel Pancreatic Cancer Drug Generating Buzz
(MedPage Today) -- The FDA has given the green light to an expanded access program (EAP) for the investigational pancreatic ...
Nearly 30 Serious Injuries Tied to Recalled Insulin Pods, FDA Says
(MedPage Today) -- Omnipod 5 insulin delivery pods subject to a class I recall have been linked to nearly 30 ...