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Showing 15 posts of 6411 posts found.

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FDA accepts sNDA for Optinose’s XHANCE

May 5, 2023 Medical Communications Ear Nose & throat, FDA, Nasal Spray, optinose, sNDA

Optinose has announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for …
News

Nanobiotix enters final contract negotiations with major pharma company

May 5, 2023 Medical Communications FDA, Oncology, nanobiotix, oncology

French late-stage clinical biotechnology company Nanobiotix has announced that it has entered into final contract negotiations with a major pharmaceutical …
News
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Cognixion receives FDA Breakthrough Device Designation for assisted communication device

May 5, 2023 Medical Communications Cognixion, FDA, Neurology, brain computer interface, breakthrough device designation, neuroscience

Cognixion, a developer of non-invasive Brain-Computer Interface (BCI) and Augmented Reality (AR) technology, has announced that the US Food and …
News

PureTech Health’s Founded Entity Akili announces positive data from adult ADHD trial

May 4, 2023 Medical Communications ADHD, Akili, Neurology, PureTech Health, clinical trials

Clinical-stage biotherapeutics company PureTech Health has reported that its Founded Entity Akili, a digital medicine company, has announced positive topline …
News

FDA approves world’s first RSV vaccine

May 4, 2023 Medical Communications FDA, RSV, Vaccine, Virology

The US Food and Drug Administration (FDA) has announced that it has approved the world’s first respiratory syncytial virus (RSV) …
News

NICE recommends Otsuka’s Lupkynis (voclosporin) in combination treatment for active lupus nephritis

May 4, 2023 Medical Communications MHRA, NICE, Nephrology, Otsuka Pharmaceuticals, lupus nephritis

Otsuka Pharmaceuticals has announced that the National Institutes for Health and Care Excellence (NICE) has recommended Lupkynis (voclosporin) in combination …
News

Avadel Pharmaceuticals granted FDA final approval for narcolepsy drug

May 3, 2023 Medical Communications FDA, FDA Approval, Neurology, avadel pharmaceuticals, narcolepsy, new drug approvals

Irish biopharmaceutical company Avadel Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted final approval and …
News

Tempus receives FDA Premarket Approval for in vitro diagnostic scan

May 3, 2023 Medical Communications Diagnostics, FDA, Oncology, Tempus, in vitro

US-based artificial intelligence (AI) and precision medicine company Tempus has announced that the US Food and Drug Administration (FDA) has …
News
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GSK’s RSV vaccine candidate gains positive EMA CHMP opinion

April 27, 2023 Medical Communications

GSK has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has shared a …
News

FDA approves first orally-administered faecal microbiota product for preventing serious gut infection

April 27, 2023 Medical Communications

The US Food and Drug Administration (FDA) has announced that it has approved the first orally-ingested faecal microbiota product for …
News
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NICE recommends two CAR T treatments for blood cancers to the Cancer Drugs Fund

April 27, 2023 Medical Communications

The National Institute for Health and Care Excellence (NICE) has announced that it is recommending two personalised immunotherapy treatments to …
News

FDA shares safety warning on amniotic fluid eyedrops

April 26, 2023 Medical Communications

The US Food and Drug Administration (FDA) has released a Public Safety Notification on eyedrops containing amniotic fluid currently being …
News
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FDA grants accelerated approval for QALSODY (tofersen) as ALS treatment

April 26, 2023 Medical Communications

Biogen has announced that the US Food and Drug Administration (FDA) has approved QALSODY (tofersen) 100mg/15ml injection for the treatment …
News
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UCB and Huma Therapeutics collaborate on digital health solution to improve rare disease management

April 26, 2023 Medical Communications

Digital health company Huma Therapeutics and biopharmaceutical company UCB are partnering to offer a digital technology solution to aid patients …
News
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Abbott announces two FDA clearances for life support system

April 26, 2023 Medical Communications

US-based medical devices and healthcare company Abbott has announced two new clearances from the US Food and Drug Administration (FDA) …
News
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Kainova Therapeutics expands phase I/II trial of antibody drug

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