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Showing 15 posts of 1442 posts found.

FDA approves Mission Therapeutics’ phase 2 clinical trial for acute kidney injury treatment

December 14, 2023
Medical Communications FDA, Mission Therapeutics, Nephrology, acute kidney injury, clinical trial

Mission Therapeutics has announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application …

News

FDA grants Kyverna Therapeutics fast track designation for myasthenia gravis treatment

December 14, 2023
Medical Communications FDA, Kyverna Therapeutics, Musculo-skeletal disorder, myasthenia gravis

Kyverna Therapeutics has announced that it has gained fast track designation from the US Food and Drug Administration (FDA) for …

News

FDA approves Novartis’ Fabhalta for PNH treatment

December 6, 2023
Medical Communications FDA, Fabhalta, Haematology, Novartis, PNH

Novartis has announced that the US Food and Drug Administration has approved Fabhalta (iptacopan) as the first oral monotherapy for …

News

Eli Lilly’s Jaypirca approved in US for leukaemia and lymphoma treatment

December 4, 2023
Medical Communications Eli Lilly, FDA, Jaypirca, Oncology, leukaemia, lymphoma

Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Jaypirca (pirtobrutinib, 100mg and 50mg tablets) …

News

FDA accepts NDA for Karuna’s schizophrenia treatment

November 30, 2023
Medical Communications FDA, Karuna Therapeutics, NDA, Neurology, schizophrenia

Karuna Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for …

News

Vivos Therapeutics gains FDA 510(k) clearance for sleep apnea treatment device

November 30, 2023
Medical Communications Devices, FDA, Vivos Therapeutics, sleep apnea

Vivos Therapeutics has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the …

News
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FDA grants breakthrough device designation to Inflammatix’s TriVerity Acute Infection and Sepsis Test System

November 29, 2023
Research and Development FDA, Infections and infestations, Inflammatix, TriVerity, infection, sepsis

Inflammatix has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s lead …

News

FDA accepts new drug application for Orexo’s opioid overdose medication

November 28, 2023
Research and Development FDA, Opioid overdose, Pharmacy, opioids, orexo

Orexo has announced that its New Drug Application (NDA) for OX124 has been accepted for review by the US Food …

News

Arcturus Therapeutics gains FDA ODD for cystic fibrosis treatment

November 28, 2023
Research and Development Arcturus Therapeutics, Chronic Diseases, FDA, ODD, cystic fibrosis

Arcturus Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ARCT-032, …

News

Alladapt Immunotherapeutics gains FDA Fast Track Designation for ADP101 as food allergy treatment

November 24, 2023
Research and Development Alladapt Immunotherapeutics, Allergic Disorders, FDA, fast track designation, food allergy

Alladapt Immunotherapeutics has announced that ADP101 has received Fast Track Designation from the US Food and Drug Administration (FDA) as …

News

FDA approves AstraZeneca’s Truqap plus Faslodex for breast cancer treatment

November 17, 2023
Medical Communications AstraZeneca, FDA, Faslodex, Oncology, breast cancer

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Truqap (capivasertib) in combination with Faslodex (fullvestrant) …

News

FDA approves Merck’s Keytruda for gastric cancer treatment

November 17, 2023
Medical Communications FDA, MSD, Merck, Oncology, gastric cancer, keytruda

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

News

FDA approves BMS’s Augtyro for lung cancer treatment

November 16, 2023
Medical 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 …

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Eli Lilly’s Zepbound approved by FDA for chronic weight management

November 9, 2023
Medical 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 …

News

J&J’s to submit surgical robot to FDA in 2024

November 8, 2023
Research 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 …

News
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