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Showing 15 posts of 1404 posts found.

FDA approves first treatment for liver scarring due to fatty liver disease

March 15, 2024
Medical Communications Endocrinology, FDA, fatty liver disease, liver scarring, nash

The US Food and Drug Administration (FDA) has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult …

News

BeiGene’s Brukinsa gains FDA accelerated approval for follicular lymphoma treatment

March 8, 2024
Medical Communications BeiGene, Brukinsa, FDA, Oncology, follicular lymphoma

BeiGene has announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Brukinsa (zanubrutinib) for the …

News

FDA approves Sandoz’s denosumab biosimilars

March 6, 2024
Medical Communications FDA, Jubbonti, Musculo-skeletal disorder, Sandoz, Wyost, denosumab

Sandoz has announced that the US Food and Drug Administration (FDA) has approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), which are …

News

FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment

March 4, 2024
Medical Communications FDA, Johnson & Johnson, NSCLC, Oncology, Rybrevant

Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority …

News

Spero Therapeutics’ bacterial infection treatment gains FDA IND clearance

February 29, 2024
Medical Communications FDA, Infections and infestations, Spero Therapeutics, bacterial infections, investigational new drug

Spero Therapeutics has announced that it has gained US Food and Drug Administration (FDA) clearance for the investigational new drug …

News

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 …

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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 …

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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) …

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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
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

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Ardena announces €20m expansion following first GMP approval

April 19, 2024

Roche’s Alecensa approved by FDA as lung cancer treatment

April 19, 2024

GSK shares results from phase 3 trial for gonorrhoea treatment

April 18, 2024

Eli Lilly’s tirzepatide demonstrates efficacy in reducing sleep apnoea severity

April 18, 2024

Medincell and AbbVie enter agreement for development of next-generation injectables

April 17, 2024