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Showing 15 posts of 1409 posts found.

Fresenius Medical Care gains FDA 501(k) clearance for haemodialysis system

February 9, 2024
Medical Communications 501(k), FDA, Fresenius Medical Care, Nephrology, dialysis

Fresenius Medical Care has announced that it has received US Food and Drug Administration (FDA) 501(k) clearance for its 5008X …

News
volodymyr-hryshchenko-m1hq4ibp9rc-unsplash

FDA grants ODD to Revolo Biotherapeutics’ eosinophilic esophagitis treatment

February 1, 2024
Medical Communications FDA, ODD, Pharmacy, Revolo Biotherapeutics, eosinophilic esophagitis

Revolo Biotherapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, …

News

FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

January 30, 2024
Research and Development FDA, Gracell Biotechnologies, Oncology, clinical trial, multiple myeloma

Gracell Biotechnologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, …

News

FDA approves Balversa for bladder cancer treatment

January 22, 2024
Medical Communications Balversa, FDA, Johnson & Johnson, Oncology, bladder cancer

Johnson & Johnson (J&J) have announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug …

News

Verastem Oncology gains Fast Track Designation for combination NSCLC treatment

January 19, 2024
Medical Communications Cancer, FDA, NSCLC, Oncology, Verastem Oncology

Verastem Oncology has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s …

News

FDA clears DermaSensor’s AI detection device for skin cancer

January 18, 2024
Medical Communications FDA, Oncology, skin cancer

DermaSensor has announced that the US Food and Drug Administration (FDA) has granted clearance for its real-time, non-invasive skin cancer …

News

FDA clears Aruna Bio’s IND for AB126 to enter clinical trials

January 17, 2024
Research and Development Aruna Bio, FDA, IND, Neurology, clinical trials

Aruna Bio has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application …

News

FDA approves Merck’s Keytruda with chemoradiotherapy as cervical cancer treatment

January 15, 2024
Medical Communications FDA, Oncology, cervical cancer, keytruda

Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) …

News

Renovos Biologics gains FDA Breakthrough Device Designation for Renovite

January 4, 2024
Medical Communications FDA, Musculo-skeletal disorder, Renovos Biologics, breakthrough device designation

Renovos Biologics has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its lead …

News

Calliditas Therapeutics gains FDA approval of Tarpeyo

December 22, 2023
Medical Communications Calliditas, FDA, Nephrology, kidneys

Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has approved Tarpeyo (budesonide) delayed release capsules to …

News

FDA approves AstraZeneca and Ionis’s Wainua

December 22, 2023
Medical Communications AstraZeneca, FDA, Ionis, Neurology, Wainua

AstraZeneca and Ionis have announced that the US Food and Drug Administration (FDA) has approved Wainua (eplontersen) for the treatment …

News

FDA approves Glaukos’ iDose TR treatment for glaucoma disease

December 15, 2023
Medical Communications FDA, Glaukos, Opthalmology, iDose TR, ocular hypertension, open-angle glaucoma

Glaukos Corporation has announced that the US Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for …

News

FDA approves Mission Therapeutics’ phase 2 clinical trial for acute kidney injury treatment

December 14, 2023
Medical Communications FDA, Mission Therapeutics, Nephrology, acute kidney injury, clinical trial

Mission Therapeutics has announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application …

News

FDA grants Kyverna Therapeutics fast track designation for myasthenia gravis treatment

December 14, 2023
Medical Communications FDA, Kyverna Therapeutics, Musculo-skeletal disorder, myasthenia gravis

Kyverna Therapeutics has announced that it has gained fast track designation from the US Food and Drug Administration (FDA) for …

News

FDA approves Novartis’ Fabhalta for PNH treatment

December 6, 2023
Medical Communications FDA, Fabhalta, Haematology, Novartis, PNH

Novartis has announced that the US Food and Drug Administration has approved Fabhalta (iptacopan) as the first oral monotherapy for …

News

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