FDA
FDA accepts UCB’s sBLA for Bimzelx
April 5, 2024Medical Communications Bimzelx, FDA, Pharmacy, UCB, sBLA
UCB has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application …
FDA approves Basilea’s antibiotic Zevtera for three indications
April 4, 2024Medical Communications Basilea Pharmaceutica, FDA, Infections and infestations, Zevtera, antibiotic
Basilea Pharmaceutica has announced that the US Food and Drug Administration (FDA) has approved Zevtera (ceftobiprole medocaril sodium for injection), …
FDA approves Eko Health’s AI for heart failure detection
April 3, 2024Medical Communications Cardiology, Eko Health, FDA, heart failure, low ejection fraction
Eko Health has announced that the US Food and Drug Administration (FDA) has approved its Low Ejection Fraction (Low EF) …
FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment
April 2, 2024Research 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 …
FDA approves Roche’s test for malaria in blood donors
April 2, 2024Business 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 …
FDA approves Merck’s Winrevair for PAH treatment
March 27, 2024Medical 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) …
Heidelberg Pharma gains FDA ODD for ATAC candidate
March 27, 2024Research 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) …
FDA approves AstraZeneca’s Ultomiris for NMOSD treatment
March 25, 2024Medical 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 …
FDA approves J&J’s Opsynvi for PAH treatment
March 25, 2024Medical 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) …
FDA approves Idorsia’s Tryvio for treatment of high blood pressure
March 22, 2024Medical 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 …
Boehringer Ingelheim’s Spevigo gains additional approvals in US and China
March 20, 2024Medical 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 …
FDA approves first treatment for liver scarring due to fatty liver disease
March 15, 2024Medical 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 …
BeiGene’s Brukinsa gains FDA accelerated approval for follicular lymphoma treatment
March 8, 2024Medical 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 …
FDA approves Sandoz’s denosumab biosimilars
March 6, 2024Medical 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 …
FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment
March 4, 2024Medical 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 …
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