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Showing 15 posts of 1442 posts found.

Angiex’s IND application for AGX101 cleared by FDA

November 3, 2023
Medical Communications AGX101, Angiex, FDA, Oncology

Angiex has announced that the US Food and Drug Administration has cleared its Investigational New Drug (IND) application for AGX101, …

News

FDA approves Phathom Pharmaceuticals’ Voquezna for erosive GERD

November 3, 2023
Medical Communications Erosive GERD, FDA, Gastrointestinal tract, Phathom Pharmaceuticals, Voquezna

Phathom Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has approved Voquenza (vonoprazan) tablets 10mg and 20mg, …

News

Roche’s Vabysmo approved by FDA for retinal vein occlusion treatment

October 27, 2023
Medical Communications FDA, Opthalmology, Roche, Vabysmo, retinal vein occlusion

Roche has announced that the US Food and Drug Administration (FDA) has approved Vabysmo (farcimab) for the treatment of macular …

News

Eli Lilly’s Omvoh receives FDA approval for ulcerative colitis treatment

October 27, 2023
Medical Communications Eli Lilly, FDA, Gastrointestinal tract, Omvoh, ulcerative colitis

Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) infusion (300mg/15mL)/injection (100mg/mL) for …

News

FDA approves Servier Pharmaceuticals’ new MDS therapy

October 25, 2023
Medical Communications FDA, Oncology, Servier Pharmaceuticals, myelodysplastic syndromes

The US Food and Drug Administration (FDA) has announced that it has approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for the treatment …

News

AstraZeneca’s sBLA for FluMist Quadrivalent accepted by FDA

October 24, 2023
Medical Communications AstraZeneca, FDA, FluMist, Immunology, flu vaccine, sBLA

AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Agreement …

News

FDA accepts Sun Pharma’s NDA for deuruxolitinib

October 6, 2023
Medical Communications Dermatology, FDA, NDA, SUun Pharma, deuruxolitinib

India-based pharma company Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has accepted its New …

News

FDA grants marketing authorisation to DNA test for predisposition to certain cancers

October 2, 2023
Research and Development FDA, Invitae, Oncology, cancer testing, oncology

The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the Invitae Common Hereditary Cancers Panel, …

News

Biogen’s biosimilar Tofidence approved by FDA

October 2, 2023
Medical Communications Actemra, Biogen, FDA, Musculo-skeletal disorder, Tofidence

Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) as an intravenous formulation, a …

News
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Karuna Therapeutics submits NDA to FDA for schizophrenia treatment

September 29, 2023
Medical Communications FDA, Karuna Therapeutics, Neurology, mental health, schizophrenia

Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration …

News

Regeneron and Sanofi’s sBLA for Dupixent accepted by FDA for priority review

September 26, 2023
Medical Communications Dupixent, Ear Nose & throat, FDA, Regeneron, Sanofi

Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has accepted their supplemental Biologics License …

News

FDA approves Eli Lilly and Boehringer Ingelheim’s Jardiance for chronic kidney disease treatment

September 25, 2023
Medical Communications Boehringer Ingelheim, Eli Lilly, FDA, Nephrology, chronic kidney disease

Eli Lilly and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10mg …

News

FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

September 22, 2023
Medical Communications FDA, Haematology, Nexcella, amyloidosis

Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to NXC-201 for …

News

GSK’s Ojjaara approved by FDA for patients with myelofibrosis and anaemia

September 18, 2023
Medical Communications FDA, GSK, Haematology, Ojjaara, anaemia, myelofibrosis

GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate …

News

Madrigal Pharmaceuticals’ NDA for resmetirom accepted by FDA

September 14, 2023
Medical Communications FDA, Internal Medicine, Madrigal Pharma, nash, resmetirom

Madrigal Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application …

News
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