FDA

All articles by FDA

FDA black box warning for antidepressants may have unintended consequences
FDA black box warning for antidepressants may have unintended consequences
Lecia Bushak
October 9, 2024
12:02 pm

Recent research suggests that the FDA’s black box warning for antidepressants may have had the opposite effect it intended.

FDA’s promised rules on pulse oximeters unlikely to end decades of racial bias
FDA’s promised rules on pulse oximeters unlikely to end decades of racial bias
Arthur Allen, KFF Health News
October 7, 2024
9:39 am

State attorneys general and U.S. senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse health outcomes.

Bristol Myers Squibb wins FDA approval for first new schizophrenia drug in 30 years
Bristol Myers Squibb wins FDA approval for first new schizophrenia drug in 30 years
Lecia Bushak
September 27, 2024
2:06 pm

Cobenfy targets cholinergic receptors instead of the dopamine receptors long addressed in current schizophrenia drugs — a new treatment approach to the disease.

Dexcom launches OTC continuous glucose monitor Stelo
Dexcom launches OTC continuous glucose monitor Stelo
Jack O'Brien
August 26, 2024
4:31 pm

The primary value differentiator for Dexcom’s Stelo is its ability to provide users with real-time glucose data and insights.

Lykos cuts 75% of staff following FDA rejection of MDMA treatment
Lykos cuts 75% of staff following FDA rejection of MDMA treatment
Jack O'Brien
August 15, 2024
3:12 pm

Lykos said the remaining full-timers would be focused on the company’s ongoing clinical development, medical affairs and engagement with the FDA.

The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use
The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use
David Hilzenrath, KFF Health News
August 15, 2024
10:00 am

When it comes to medical devices, recalls can include not only ‘removals,’ in which the device is removed from where it is used or sold, but also ‘corrections,’ which address the problem in the field

A bad weekend for MDMA treatments, unpacked.
A bad weekend for MDMA treatments, unpacked.
Jack O'Brien
August 12, 2024
11:30 am

In response to the decision, Lykos said it would request a meeting with the FDA to ask for a reconsideration of the decision and discuss the recommendations for a resubmission for approval.

Adaptimmune’s Tecelra gains accelerated FDA approval for synovial sarcoma
Adaptimmune’s Tecelra gains accelerated FDA approval for synovial sarcoma
Lecia Bushak
August 2, 2024
12:34 pm

Adaptimmune Therapeutics noted the FDA accelerated approval of Tecelra marked a ‘watershed moment’ for patients with synovial sarcoma.

Why millions are trying FDA-authorized alternatives to Big Pharma’s weight loss drugs
Why millions are trying FDA-authorized alternatives to Big Pharma’s weight loss drugs
Arthur Allen, KFF Health News
July 23, 2024
2:00 pm

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply.

FDA details how pharma companies can counter health misinformation
FDA details how pharma companies can counter health misinformation
Lecia Bushak
July 11, 2024
11:44 am

In a long-awaited move, the FDA released a draft guidance for how the pharma industry can address misinformation about their drug products.

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