FDA Updates

The new FDA-approved presentation will be the company’s third 505(b)(2) injectable added in 2024, expected to launch in the third quarter.

Check out these important FDA updates from the month of July 2024.

Check out important updates from the FDA from over the past week.

The approval of eculizumab-aagh offers more treatment options for patients with rare diseases PNH and aHUS.

The approval offers a first of its kind treatment option for patients living with nonerosive GERD.

The companies are marketing products that may violate Federal Trade Commission prohibition of “unfair and deceptive acts in the marketplace.”

Had Novo Nordisk’s insulin icodec secured FDA approval, it would have been the first and only once-weekly basal insulin option for adults with diabetes.

The commercial product is expected to be available by the end of July.

Donanemab-azbt was approved under the FDA's Fast Track Review, Priority Review, and Breakthrough Therapy designations.

Through a test-and-treat approach, patients who test positive for HCV RNA with the Xpert HCV test and GeneXpert Xpress System can be connected to care as soon as the same health care visit.

Check out these important FDA updates from the month of June 2024.

The first-in-class selective dual PDE3 and PDE4 inhibitor from Verona Pharma is the first inhaled product with a novel mechanism of action approved to treat COPD in over 20 years.

The Victoza generic is approved for use in adults and children aged 10 years and older.

Check out important updates from the FDA for the week of June 17.

Cefepime/enmetazobactam was granted a 5-year exclusivity extension under GAIN Act legislation.

The vaccine covers 8 serotypes not currently covered by any FDA-approved pneumococcal vaccines.

The therapy from AstraZeneca is indicated to improve glycemic control in patients aged 10 years or older.

The Lingo and Libre Rio from Abbott are based on the company’s FreeStyle Libre sensing technology.

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses how some of the concern’s raised by the panel can inform future psychedelic research.

The new task force highlights a stronger government focus on curbing the risks of e-cigarettes for young people, especially after sustained calls for stricter action on the public health issue by lawmakers and the public.

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, talks about some of the problems he saw during the Psychopharmacologic Drugs Advisory Committee meeting.

Check out important updates from the FDA for the week of June 3.

The Psychopharmacologic Drugs Advisory Committee voted 10-1 that the benefits of MDMA do not outweigh its potential risks.

The SpeedySwab COVID + FLU A&B Self-Test from Watmind is intended for at-home and point-of-care use and can simultaneously detect COVID-19, influenza A, and influenza B in 15 minutes.

mRESVIA is the first mRNA vaccine approved for a disease other than COVID-19.

Check out these important FDA updates from the month of May 2024.

The approval of Lisocabtagene maraleucel (Breyanzi; liso-cel) was based on data from the TRANSCEND-NHL-001 study, in which the therapy showed rapid and durable response rates.

The drug will be available in pharmacies during the second half of 2024.

Eculizamab-aeeb is the 53rd FDA-approved biosimilar in the US.

Check out important updates from the FDA for the week of May 20.