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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. Are you hiring?

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UK approves prescription-only melatonin drug for childhood ADHD

Pharmaceutical Technology

Melatonin has a prescription-only status and is strictly regulated in the UK, making this the first time it has been approved for use in this indication. In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment.

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Are new weight loss drugs an answer or problem?

World of DTC Marketing

Unpaid celebrity endorsements include venture capitalist Marc Andreessen, who says the drug completely changed his relationship with food, and Elon Musk, who has cited it on Twitter. Payers also face hurdles, so patients must obtain permission before filling a prescription. So far, the data for Wegovy looks excellent.

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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 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). A progressive and fatal neurodegenerative ailment, ALS is caused by the death of motor neurons in the brain and spinal cord.

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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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Getting an Rx does not address health problems

World of DTC Marketing

Pharma websites provide the prescription that can help people overcome health problems but too often, they ignore the patient’s responsibility to lose weight and exercise. While the population is more worried about COVID, they are killing themselves by overeating processed food and not getting any exercise.

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