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FDA

Showing 15 posts of 1404 posts found.

FDA clears DermaSensor’s AI detection device for skin cancer

January 18, 2024
Medical Communications FDA, Oncology, skin cancer

DermaSensor has announced that the US Food and Drug Administration (FDA) has granted clearance for its real-time, non-invasive skin cancer …

News

FDA clears Aruna Bio’s IND for AB126 to enter clinical trials

January 17, 2024
Research and Development Aruna Bio, FDA, IND, Neurology, clinical trials

Aruna Bio has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application …

News

FDA approves Merck’s Keytruda with chemoradiotherapy as cervical cancer treatment

January 15, 2024
Medical Communications FDA, Oncology, cervical cancer, keytruda

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

News

Renovos Biologics gains FDA Breakthrough Device Designation for Renovite

January 4, 2024
Medical Communications FDA, Musculo-skeletal disorder, Renovos Biologics, breakthrough device designation

Renovos Biologics has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its lead …

News

Calliditas Therapeutics gains FDA approval of Tarpeyo

December 22, 2023
Medical Communications Calliditas, FDA, Nephrology, kidneys

Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has approved Tarpeyo (budesonide) delayed release capsules to …

News

FDA approves AstraZeneca and Ionis’s Wainua

December 22, 2023
Medical Communications AstraZeneca, FDA, Ionis, Neurology, Wainua

AstraZeneca and Ionis have announced that the US Food and Drug Administration (FDA) has approved Wainua (eplontersen) for the treatment …

News

FDA approves Glaukos’ iDose TR treatment for glaucoma disease

December 15, 2023
Medical Communications FDA, Glaukos, Opthalmology, iDose TR, ocular hypertension, open-angle glaucoma

Glaukos Corporation has announced that the US Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for …

News

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

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Ardena announces €20m expansion following first GMP approval

April 19, 2024

Roche’s Alecensa approved by FDA as lung cancer treatment

April 19, 2024

GSK shares results from phase 3 trial for gonorrhoea treatment

April 18, 2024

Eli Lilly’s tirzepatide demonstrates efficacy in reducing sleep apnoea severity

April 18, 2024

Medincell and AbbVie enter agreement for development of next-generation injectables

April 17, 2024