FDA
FDA approves BMS’s Augtyro for lung cancer treatment
November 16, 2023Medical Communications FDA, Oncology, bristol myers squibb, lung cancer
Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has approved Augtyro (repotrectinib) for the treatment …
Eli Lilly’s Zepbound approved by FDA for chronic weight management
November 9, 2023Medical Communications Eli Lilly, FDA, Obesity, Zepbound, weight loss, weight management
Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Zepbound (tirzepatide) injection for chronic weight …
J&J’s to submit surgical robot to FDA in 2024
November 8, 2023Research and Development FDA, J&J, Johnson & Johnson MedTech, Pharmacy, surgical robot
Johnson & Johnson MedTech have announced plans to submit the Ottava robotic surgical system to the US Food and Drug …
Angiex’s IND application for AGX101 cleared by FDA
November 3, 2023Medical 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, …
FDA approves Phathom Pharmaceuticals’ Voquezna for erosive GERD
November 3, 2023Medical 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, …
Roche’s Vabysmo approved by FDA for retinal vein occlusion treatment
October 27, 2023Medical 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 …
Eli Lilly’s Omvoh receives FDA approval for ulcerative colitis treatment
October 27, 2023Medical 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 …
FDA approves Servier Pharmaceuticals’ new MDS therapy
October 25, 2023Medical 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 …
AstraZeneca’s sBLA for FluMist Quadrivalent accepted by FDA
October 24, 2023Medical 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 …
FDA accepts Sun Pharma’s NDA for deuruxolitinib
October 6, 2023Medical 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 …
FDA grants marketing authorisation to DNA test for predisposition to certain cancers
October 2, 2023Research 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, …
Biogen’s biosimilar Tofidence approved by FDA
October 2, 2023Medical 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 …
Karuna Therapeutics submits NDA to FDA for schizophrenia treatment
September 29, 2023Medical 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 …
Regeneron and Sanofi’s sBLA for Dupixent accepted by FDA for priority review
September 26, 2023Medical 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 …
FDA approves Eli Lilly and Boehringer Ingelheim’s Jardiance for chronic kidney disease treatment
September 25, 2023Medical 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 …
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Five Facts about cardiovascular disease
