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Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

Legacy MEDSearch

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. BabySat is a step forward in solving some of these exact challenges by bringing real-time medical grade infant monitoring into the home, while under the supervision of a physician.

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FDA grants approval for Amylyx’s Relyvrio to treat ALS

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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US FDA accepts Optinose’s sNDA for chronic rhinosinusitis therapy Xhance

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). The therapy is being offered immediately through prescription for eligible ALGS patients.

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FDA makes moves to advance ALS research ahead of upcoming Amylyx AdCom

Pharmaceutical Technology

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. The first AdCom was critical of the study’s robustness.

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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. .

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HeartBeam Announces Acquisition of LIVMOR Assets

Legacy MEDSearch

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.