FDA
FDA approved Ipsen’s Sohonos capsules for treatment of fibrodysplasia ossificans progressiva
August 17, 2023Medical Communications FDA, FOP, Musculo-skeletal disorder, Sohonos, ipsen
Ipsen has announced that the US Food and Drug Administration (FDA) has approved Sohonos (palovarotene) capsules as a retinoid indicated …
Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo
August 17, 2023Research and Development FDA, IND, Immunology, lupus nephritis, pharma
On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ Investigational New Drug (IND) application …
Tempus receives FDA Breakthrough Device Designation for its companion diagnostic test
August 16, 2023Research and Development Diagnostics, FDA, Tempus, breakthrough device designation, diagnostic
Tempus has announced that the US Food and Drug Administration (FDA) has granted it Breakthrough Device Designation for its HLA-LOH …
FDA grants accelerated approval to Pfizer’s Elrexfio
August 15, 2023Medical Communications Elrexfio, FDA, Oncology, Pfizer, accelerated approval
Pfizer has that the US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment …
FDA grants orphan drug designation to Genprex’s Reqorsa
August 15, 2023Medical Communications FDA, ODD, Oncology, Reqorsa
Gene therapy company Genprex has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) …
FDA approved Janssen’s Akeega for prostate cancer treatment
August 14, 2023Research and Development Akeega, FDA, J&J, Janssen, Oncology, prostate cancer
The Janssen Pharmaceutical companies of Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved …
FDA approves Talvey for the treatment of heavily pretreated multiple myeloma
August 11, 2023Medical Communications FDA, J&J, Janssen, Oncology, Talvey, multiple myeloma
The Janssen Pharmaceutical companies of Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has granted …
FDA accepts Astellas’ sNDA for Cresemba in children
August 11, 2023Research and Development Astella, FDA, Paediatrics, cresemba
The US Food and Drug Administration (FDA) announced it has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for Cresemba …
FDA grants clearance to next phase of Ascentage Pharma’s clinical trial for CLL/SLL treatment
August 8, 2023Research and Development Ascentage Pharma, CLL/SLL, FDA, Oncology, clinical trial
Ascentage Pharma has announced that the US Food and Drug Administration (FDA) has granted clearance for the phase 3 study …
First oral treatment for women with postpartum depression approved by FDA
August 7, 2023Research and Development FDA, postpartum depression, treatment, zurzuvae
On 4 August 2023, the US Food and Drug Administration (FDA) approved the use of Zurzuvae for adults with postpartum …
Astellas announces FDA approval for Izervay for GA treatment
August 7, 2023Medical Communications AMD, Astellas Pharma, FDA, Izervay, Opthalmology, geographic atrophy
Astellas Pharma has announced that the US Food and Drug Administration (FDA) has approved Izervay (avacincaptag pegol intravitreal solution) for …
FDA approves Merck’s Ervebo vaccine for under 18s
August 4, 2023Research and Development FDA, Immunology, Vaccine, ebolavirus
On 3 August 2023, the US Food and Drug Administration (FDA) approved Merck’s Ervebo vaccine for children over 12 months. …
FDA approves Taiho’s Lonsurf for metastatic colorectal cancer treatment
August 3, 2023Medical Communications FDA, Lonsurf, Oncology, colorectal cancer, mCRC, taiho
Taiho Oncology and Taiho Pharmaceutical have announced that the US Food and Drug Administration (FDA) has approved Lonsurf (trifluridine/tipiracil) as …
FDA grants ODD to ABM Therapeutics’ treatment for patients with glioblastoma
August 3, 2023Medical Communications ABM Therapeutics, ABM-1310, FDA, Oncology, glioblastoma
ABM Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310. …
GSK’s Jemperli approved for treatment of endometrial cancer
August 1, 2023Research and Development FDA, GSK, Jemperli, Oncology, dostarlimab, endometrial cancer
GSK has announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and …
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