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FDA Approves Expanded Label for Dapagliflozin to Reduce Risk of Cardiovascular Death, Hospitalization from Heart Failure

Pharmacy Times

Dapagliflozin was established as the first SGLT2 inhibitor that demonstrated a mortality benefit for cardiovascular death from heart failure.

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12 Medications With Off-Label Uses

BuzzRx

Food and Drug Administration (FDA) has to undergo several rigorous phases before approving new medications. Once the FDA approves a new drug, it means that when using this drug for an approved condition, the potential benefits outweigh the potential risks. The term “on-label use” of a drug may seem unfamiliar to most people.

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Lexicon gets FDA approval for Inpefa to treat heart failure

Pharmaceutical Technology

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1).

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FDA approves omaveloxolone for treatment of Friedreich’s Ataxia

Hospital Pharmacy Europe

In an open label extension trial, after 72 weeks, the response to omaveloxolone compared to placebo was maintained. The post FDA approves omaveloxolone for treatment of Friedreich’s Ataxia appeared first on Hospital Pharmacy Europe.

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STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety.

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Relief for Amylyx as FDA clears controversial ALS drug Relyvrio

pharmaphorum

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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FDA Approvals: September 2022 Recap

Digital Pharmacist

The FDA protects public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices. It is critical for the FDA to continue to develop new advances in therapies to aid our communities in order to achieve better lives through better health. Date of Approval: 9/30/2022.

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