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Showing 15 posts of 1442 posts found.

FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment

April 2, 2024
Research and Development AstraZeneca, Daiichi Sankyo, FDA, Oncology, bla, breast cancer

AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-Dxd) has been accepted in …

News

FDA approves Roche’s test for malaria in blood donors

April 2, 2024
Business Services FDA, Infections and infestations, blood donation, malaria

Roche has announced that the US Food and Drug Administration (FDA) has approved its cobas Malaria test for use on …

News

FDA approves Merck’s Winrevair for PAH treatment

March 27, 2024
Medical Communications Cardiology, FDA, Merck, Winrevair, pulmonary arterial hypertension

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

News

Heidelberg Pharma gains FDA ODD for ATAC candidate

March 27, 2024
Research and Development FDA, Oncology, heidelberg pharma, multiple myeloma

Heidelberg Pharma has announced that it has gained Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) …

News

FDA approves AstraZeneca’s Ultomiris for NMOSD treatment

March 25, 2024
Medical Communications AstraZeneca, FDA, Neurology, Ultomiris, neuromyelitis optica spectrum disorder

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvs) as the first and only …

News

FDA approves J&J’s Opsynvi for PAH treatment

March 25, 2024
Medical Communications Cardiology, FDA, J&J, Johnson & Johnson, Opsynvi, pulmonary arterial hypertension

Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil) …

News

FDA approves Idorsia’s Tryvio for treatment of high blood pressure

March 22, 2024
Medical Communications Cardiology, FDA, Tryvio, blood pressure, blood presure, hypertension

Idorsia has announced that the US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension …

News

Boehringer Ingelheim’s Spevigo gains additional approvals in US and China

March 20, 2024
Medical Communications Boehringer Ingelheim, Dermatology, FDA, Spevigo, psoriasis

Boehringer Ingelheim has announced that Spevigo (spesolimab-sbzo) has been approved by the US Food and Drug Administration (FDA) for the …

News

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 …

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
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