FDA
Calliditas Therapeutics gains FDA approval of Tarpeyo
December 22, 2023Medical 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 …
FDA approves AstraZeneca and Ionis’s Wainua
December 22, 2023Medical 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 …
FDA approves Glaukos’ iDose TR treatment for glaucoma disease
December 15, 2023Medical 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 …
FDA approves Mission Therapeutics’ phase 2 clinical trial for acute kidney injury treatment
December 14, 2023Medical 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 …
FDA grants Kyverna Therapeutics fast track designation for myasthenia gravis treatment
December 14, 2023Medical 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 …
FDA approves Novartis’ Fabhalta for PNH treatment
December 6, 2023Medical 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 …
Eli Lilly’s Jaypirca approved in US for leukaemia and lymphoma treatment
December 4, 2023Medical 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) …
FDA accepts NDA for Karuna’s schizophrenia treatment
November 30, 2023Medical 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 …
Vivos Therapeutics gains FDA 510(k) clearance for sleep apnea treatment device
November 30, 2023Medical 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 …
FDA grants breakthrough device designation to Inflammatix’s TriVerity Acute Infection and Sepsis Test System
November 29, 2023Research 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 …
FDA accepts new drug application for Orexo’s opioid overdose medication
November 28, 2023Research 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 …
Arcturus Therapeutics gains FDA ODD for cystic fibrosis treatment
November 28, 2023Research 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, …
Alladapt Immunotherapeutics gains FDA Fast Track Designation for ADP101 as food allergy treatment
November 24, 2023Research 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 …
FDA approves AstraZeneca’s Truqap plus Faslodex for breast cancer treatment
November 17, 2023Medical 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) …
FDA approves Merck’s Keytruda for gastric cancer treatment
November 17, 2023Medical 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 …
