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Showing 15 posts of 1409 posts found.

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

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

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