Healthline

FDA Approves Wegovy Weight Loss Pill: How It Compares to Injectables

The weight loss drug Wegovy is now available as a tablet in more than 70,000 U.S. pharmacies as well as select telehealth ...
STAT

FDA approves first new gonorrhea drug in decades

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...
MedPage Today

Myasthenia Gravis Gets a New Drug Approval

The FDA expanded the indication of inebilizumab (Uplizna) to include generalized myasthenia gravis (gMG), Amgen announced Friday. The drug is now approved to treat gMG in adults who are ...
FierceBiotech

FDA approves 1st nondrug, at-home treatment for depression

The FDA has approved its first at-home, nondrug therapy for depression, with a wearable brain stimulation headset developed by Flow Neuroscience. The agency issued a green light that covers the device ...
STAT

In a first, a nonprofit wins FDA approval for rare disease gene therapy

Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71. The Food and Drug Administration this week granted approval to a new gene ...
Reuters

US FDA approves first at-home device for depression

Dec 11 (Reuters) - The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that ...
CNN

With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins

The US Food and Drug Administration on Monday approved a daily pill version of Novo Nordisk’s weight-loss drug Wegovy, introducing a new option for how patients can take medicines in a class of drugs ...
MedPage Today

Lowering FDA's Drug-Approval Standards Is a Lose-Lose

Last week, FDA Commissioner Marty Makary, MD, MPH, announced plans to officially lower the standard for how many clinical trials are needed to approve a new drug -- from the long-standing expectation ...
Business Wire

FDA Approves USAntibiotics' Augmentin XR in Historic First for Expedited Review Program

BRISTOL, Tenn.--(BUSINESS WIRE)--USAntibiotics, the country's only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced today that the U.S. Food and Drug ...
FiercePharma

Cincinnati's LIB scores FDA approval for 3rd-generation PCSK9 drug Lerochol

LIB Therapeutics has scored an FDA approval for its cholesterol-lowering, third-generation PCSK9 inhibitor, lerodalcibep-liga. The injected treatment, which will carry the commercial name Lerochol, is ...
FiercePharma

Italian nonprofit lands FDA approval for 1st gene therapy to treat rare genetic disease

The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione ...
Reuters

GSK wins US approval for twice-yearly asthma drug

LONDON, Dec 16 (Reuters) - The U.S. health regulator has approved GSK's (GSK.L), opens new tab add-on treatment for severe asthma, offering a less frequently dosed option, but rejected its use for ...