FDA

Showing 15 posts of 1340 posts found.

Otsuka and Lundbeck gain FDA approval for supplemental New Drug Application for dementia drug

May 11, 2023
Medical Communications FDA, Lundbeck, Neurology, Otsuka Pharmaceuticals, alzheimer's disease, dementia

Japan-based healthcare company Otsuka Pharmaceutical and Danish pharma company Lundbeck have announced that the US Food and Drug Administration (FDA) …

FDA pre-meeting report raises concerns over Sarepta’s gene therapy for Duchenne muscular dystrophy

May 11, 2023
Medical Communications Duchenne Muscular Dystrophy, FDA, Musculo-skeletal disorder, Sarepta Therapeutics, gene therapy

The US Food and Drug Administration (FDA) has released a report in preparation for its 12 May decision on Sarepta …

Eyenovia announces FDA approval of first ophthalmic spray for mydriasis

May 10, 2023
Research and Development Eyenovia, FDA, Opthalmology, mydriasis, ophthalmology

Ophthalmic technology company Eyenovia has announced that the US Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine …

AstraZeneca’s Farxiga approved to reduce risk of cardiovascular death

May 9, 2023
Medical Communications AstraZeneca, Cardiology, FDA, cvd, farxiga, heart failure

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Farxiga to reduce the risk of cardiovascular …

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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 …

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 …

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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 …

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) …

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 …

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 …

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FDA approves Pfizer’s pneumococcal conjugate vaccine for infants and children

April 28, 2023
Market Access, Research and Development, Sales and Marketing Ear Nose & throat, FDA, Immunology, Pfizer, Vaccine, pneumococcal vaccine

Pfizer has announced that the US Food and Drug Administration (FDA) has approved its PREVNAR 20 (20-valent pneumococcal conjugate vaccine) …

limbix

SparkRx depression therapeutic shown to cut depression symptoms in adolescents

October 11, 2021
Sales and Marketing FDA, Limbix, SparkRx

A new digital therapeutic available for use without prescription under the FDA’s emergency guidance for digital health devices has shown …

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Moderna and Pfizer COVID-19 vaccine protection declines over time

September 16, 2021
Business Services COVID-19, FDA, Moderna, Pfizer, comirnaty

Data presented by Pfizer and Moderna ahead of the FDA’s vaccine advisory committee meeting on Friday suggest that protection from …

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BioNTech seek approval for COVID-19 vaccine in children aged 5-11

September 13, 2021
Sales and Marketing COVID-19, FDA, Vaccine, children

Children between 5 and 11 years old are to be targeted by BioNTech as the company seeks approval for younger …

Expansion for first FDA-approved video game for ADHD treatment

July 23, 2021
Medical Communications, Research and Development ADHD, FDA, US, digital therapeutics, technology

Akili Interactive has announced the expansion of its prescription video game treatment, EndeavorRx, with the addition of new gaming features …

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