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FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD

Pharmaceutical Technology

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA will consider the AdCom as it reviews the drug’s sNDA.

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COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

The FDA Law Blog

By doing so, FDA has limited the number of tests that have reached the market, thereby reducing available supply and increasing prices. As FDA would acknowledge, the antigen tests are the fastest and most practical method for distributing testing in the general population. That could happen again.

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Biogen and Eisai’s Alzheimer’s drug secures support in closely watched AdCom

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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What was the most popular prescription in each state in 2023?

The Checkup by Singlecare

Levothyroxine (Synthroid) Most popular prescription in Arizona, Iowa, Idaho, Kansas, Maine, Montana, Nebraska, Nevada, New Mexico, Ohio, South Dakota, Vermont, and Wyoming Levothyroxine coupons In 2023, levothyroxine continued to be one of the most commonly filled medications with SingleCare, ranking number one in 13 states.

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Antidepressants and Suicide: Why Don’t People Think There’s a Link?

The People's Pharmacy

At one point, she was on multiple medications, some contraindicated. When she died, she had just been put on an antidepressant with a black-box FDA suicide warning. ” “It would be disastrous if an antidepressant medication actually produced “obsessive, recurrent, persistent and intrusive” thoughts of suicide.

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Almirall/Lilly lebrikizumab offers potential long-term management of atopic dermatitis

pharmaphorum

The FDA granted lebrikizumab Fast Track designation in December 2019. He has been a research fellow at Harvard Medical School, Boston, the University of California, San Francisco, and University Spital Zürich, Switzerland, where his research focused on atopic dermatitis and the complexity of the skin barrier.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. She also has been conducting fundamental research as an academic in several universities, with her last academic position held at Harvard Medical School. About the author. References.