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Envoy Medical QS Violations

[ Price : $8.95]

FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hea...

FDA Broadens Covid Vaccine Probe to Include Adult Deaths

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FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric d...

Experts Call for Overhaul of FDA Revolving Door Rules

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Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into p...

Prescription to Nonprescription Switch MAPP

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CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription mar...

Petition Urges FDA to Overhaul Biosimilar Approval Rules

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A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval require...

FDA OKs 1st Cellular Therapy for Severe Aplastic Anemia

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FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.

FDA Delays Safety Review of Abortion Pill Mifepristone

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FDA postpones a promised safety review of the abortion drug mifepristone and is now not likely to be released until after the 2026...

BioNTech, OncoC4 See Good Survival Data for Lung Cancer Drug

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BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for certain patients with ...

FDA Delays Decision on Agios Mitapivat sNDA for Thalassemia

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FDA delays its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both t...

Dyne Reports Strong Dystrophin Gains in Duchenne Study

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Dyne Therapeutics reports positive topline results from its Phase 1/2 DELIVER trial of z-rostudirsen (DYNE-251), saying the invest...