FDA

Showing 15 posts of 1284 posts found.

FDA approves first oral antiviral to treat adult patients with COVID-19

May 26, 2023
Medical Communications COVID-19, FDA, Infections and infestations, paxlovid

The US Food and Drug Administration (FDA) has announced that it has approved the oral antiviral Paxlovid (nirmatrelvir tablets and …

ZOLL remedē System receives FDA approval for sleep apnoea treatment

May 25, 2023
Medical Communications Ear Nose & throat, FDA, ZOLL, sleep apnoea

ZOLL Medical Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for its …

Artivion receives FDA PMA approval of PerClot; transfers designation to Baxter

May 24, 2023
Medical Communications Artivion, Baxter International, Cardiology, FDA, PMA, PerClot

US cardiac and vascular surgery company Artivion has announced that the US Food and Drug Administration (FDA) has granted a …

FDA approves Innoviva’s Xacduro for intravenous use

May 24, 2023
Medical Communications FDA, Infections and infestations, Innoviva, pneumonia

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, has announced that the US Food and Drug Administration (FDA) has approved Xacduro …

Rocket Pharmaceuticals granted FDA RMAT designation for gene therapy

May 24, 2023
Medical Communications FDA, Haematology, RMAT, Rocket Pharmaceuticals, gene therapy

Rocket Pharmaceuticals, a US-based biotechnology company, has announced that it has received US Food and Drug Administration (FDA) Regenerative Medicine …

More infections from contaminated eyedrops increase death toll

May 23, 2023
Medical Communications FDA, Opthalmology, eyedrops, infections

The US Centers for Disease Control and Prevention (CDC) have released updated data regarding contaminated eyedrops. As of May 2023, …

FDA announces acceptance and priority review of NDA for LUMISIGHT imagining agent for breast cancer

May 23, 2023
Research and Development FDA, Lumicell, Oncology, breast cancer, oncology

Lumicell has announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New …

Grünenthal receives FDA Breakthrough Therapy Designation for knee osteoarthritis drug

May 23, 2023
Medical Communications Breakthrough Therapy Designation, FDA, Grunenthal, Musculo-skeletal disorder, osteoarthritis

German pharmaceutical company Grünenthal has announced that the US Food and Drug Administration (FDA) has awarded it Breakthrough Therapy Designation …

FDA approves prescription nasal spray for opioid overdose treatment

May 23, 2023
Medical Communications FDA, Nasal Spray, Opvee, Poisoning and drug dependency, opioids, overdose

The US Food and Drug Administration (FDA) has announced that it has approved Opvee, the first nalmefene hydrochloride nasal spray …

FDA approves new insulin pump and algorithm software for enhanced automated insulin delivery

May 22, 2023
Medical Communications Devices, FDA, diabetes, insulin

The US Food and Drug Administration (FDA) has announced that it has cleared the Beta Bionics iLet ACE Pump and …

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Swing Therapeutics receives FDA authorisation for digital therapeutic for fibromyalgia

May 22, 2023
Medical Communications CBT, Devices, FDA, Swing Therapeutics, fibromyalgia

Swing Therapeutics has announced that it has received De Novo marketing authorisation from the US Food and Drug Administration for …

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Krystal Biotech secures FDA approval for redosable topical gene therapy

May 22, 2023
Medical Communications FDA, Krystal Biotech, Paediatrics, dystrophic epidermolysis bullosa, gene therapy

US-based biotech company Krystal Biotech has announced that the US Food and Drug Administration (FDA) has approved its topical gene …

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FDA committee votes in favour of Pfizer’s RSV vaccine for maternal immunisation

May 19, 2023
Research and Development FDA, Immunology, Pfizer, RSV, Vaccine, maternal immunisation

Pfizer has announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) from the US Food and Drug Administration …

FDA approves Abbott’s Assert-IQ insertable cardiac monitor

May 19, 2023
Research and Development Abbott, Cardiology, Devices, FDA, heart monitor, medical devices

Abbott has announced that the US Food and Drug Administration (FDA) has granted its clearance for the Assert-IQ insertable cardiac …

FDA grants Priority Review for Takeda’s cTTP treatment

May 17, 2023
Research and Development Biologics License Application, Cardiology, FDA, Takeda, cTTP

Japanese biopharmaceutical company Takeda has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application …

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