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Showing 15 posts of 1444 posts found.

FDA accepts BLA for Regeneron’s linvoseltamab for Priority Review

February 22, 2024
Medical Communications FDA, Oncology, Regeneron, bla, priority review

Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for …

News

argenx announces FDA acceptance of sBLA for Vyvgart Hytrulo for CIDP treatment

February 20, 2024
Medical Communications CIDP, FDA, Neurology, Vyvgart Hytrulo, argenx, sBLA

argenx has announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for …

News

FDA approves Ipsen’s Onivyde for pancreatic adenocarcinoma treatment

February 14, 2024
Medical Communications FDA, Oncology, Onivyde, ipsen, pancreatic adenocarcinoma

Ipsen has announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for …

News

J&J’s nipocalimab gains breakthrough therapy designation from FDA for HDFN treatment

February 12, 2024
Medical Communications Breakthrough Therapy Designation, FDA, HDFN, J&J, Reproductive health

Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) …

News

GSK gains FDA Fast Track designation for chronic hepatitis B treatment

February 12, 2024
Medical Communications FDA, GSK, Hepatology, fast track designation, hepatitis B

GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational …

News

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
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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) …

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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
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