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FDA approves Medtronic’s urinary incontinence treatment device
22 Sep 2025 14:59 GMT
The US Food and Drug Administration (FDA) has approved Medtronic’s Altaviva device, intended … boundaries of innovation, and this FDA approval underscores our unwavering commitment to …
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Stealth Bio’s Forzinity finally approved as first Barth syndrome therapy
22 Sep 2025 12:40 GMT
… a previous rejection, the US Food and Drug Administration (FDA) has approved Stealth BioTherapeutics’ Forzinity (elamipretide … out more
The FDA approved Forzinity via its accelerated approval pathway, a regulatory …
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US FDA grants accelerated approval to Stealth Bio’s Forzinity to improve muscle strength in adult and paediatric patients with Barth syndrome
22 Sep 2025 11:51 GMT
… announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Forzinity (elamipretide … am thrilled to have an FDA-approved treatment to offer to … .
This indication is approved under accelerated approval based on an improvement …
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J&J’s Tremfya gets FDA approval for SC induction in active UC
22 Sep 2025 11:51 GMT
… &J) has secured approval from the US Food and Drug Administration (FDA) for a subcutaneous … -controlled injector.
It was approved by the FDA for intravenous (IV) induction … were consistent with the previously approved 200mg IV induction regimen, showing …
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Merck Snags A Key Approval Before Its Cash Cow Goes Off A Patent Cliff
22 Sep 2025 14:48 GMT
The Food and Drug Administration on Friday approved an injectable version of Merck… , Just Surged Into A Breakout
FDA Slams Hims & Hers With …
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Idebenone Accepted by FDA for Priority Review for Leber Hereditary Optic Neuropathy (LHON)
22 Sep 2025 12:00 GMT
… diseases, today announced the US Food and Drug Administration (FDA) is evaluating the regulatory submission … for the FDA decision is February 28, 2026. If approved, idebenone will … idebenone will become the first FDA-approved treatment for LHON.” "LHON …
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Actuate Therapeutics Provides FDA with Updated Clinical Data Package to Support Planned Regulatory Interactions with FDA and EMA Over the Coming Months
22 Sep 2025 12:45 GMT
… with the U.S. Food and Drug Administration (FDA) and the European Medicines … anticipated interactions with the FDA and EMA. We have … results or receive regulatory approval on a timely basis, … delay or preclude regulatory approval, cause us to suspend …
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Stealth's patience rewarded as FDA approves Barth drug
22 Sep 2025 11:31 GMT
Stealth BioTherapeutics has claimed FDA approval for Forzinity, the … a swift decision on approval.
Barth syndrome mainly affects … established clinical endpoint.
The FDA initially said that knee … Reenie McCarthy, called the approval a "pivotal victory …
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Apple Watch AI Detects Hypertension Without Cuffs, FDA-Cleared
22 Sep 2025 12:16 GMT
… known hypertension markers, culminating in FDA clearance just days before the … .
Regulatory and Ethical Considerations
The FDA’s approval, announced in a Verge … ., with international rollouts pending regulatory approvals, as per recent news on …
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FDA clears subcutaneous Keytruda in a boost to MSD
22 Sep 2025 11:31 GMT
… for patients in half.
The FDA has cleared the new version … ;s total turnover.
"This approval is significant for patients and … Tecentriq (atezolizumab), have also been approved in subcutaneous versions that use …
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