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Showing 15 posts of 1442 posts found.

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 …

News
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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

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

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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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) …

News
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 …

News
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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 …

News
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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 …

News

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 …

News

New warning added to J&J vaccine in US

July 13, 2021
Manufacturing and Production COVID-19, FDA, J&J, JJ, US, Vaccine

The FDA has made the decision to add a warning to the fact sheet for Johnson & Johnson’s COVID-19 vaccine, …

News
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CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab

June 29, 2021
Manufacturing and Production CHMP, EMA, EU, FDA, US

Incyte and MorphoSys have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive …

News

Eli Lilly to seek FDA approval for experimental Alzheimer’s drug

June 25, 2021
Medical Communications Alzheimer's, Eli Lilly, FDA

Eli Lilly plans to seek accelerated FDA approval for its experimental Alzheimer’s drug donanemab, announcing plans on Thursday to file …

News
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