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FDA

Showing 15 posts of 1340 posts found.

FDA approved Ipsen’s Sohonos capsules for treatment of fibrodysplasia ossificans progressiva

August 17, 2023
Medical 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 …

News

Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

August 17, 2023
Research 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 …

News
testalize-me-0je8ynv4mis-unsplash

Tempus receives FDA Breakthrough Device Designation for its companion diagnostic test

August 16, 2023
Research 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 …

News

FDA grants accelerated approval to Pfizer’s Elrexfio

August 15, 2023
Medical 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 …

News
lungs

FDA grants orphan drug designation to Genprex’s Reqorsa

August 15, 2023
Medical 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) …

News

FDA approved Janssen’s Akeega for prostate cancer treatment

August 14, 2023
Research 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 …

News
pawel-czerwinski-2y8ol_obs1i-unsplash_2

FDA approves Talvey for the treatment of heavily pretreated multiple myeloma

August 11, 2023
Medical 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 …

News

FDA accepts Astellas’ sNDA for Cresemba in children

August 11, 2023
Research 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 …

News

FDA grants clearance to next phase of Ascentage Pharma’s clinical trial for CLL/SLL treatment

August 8, 2023
Research 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 …

News

First oral treatment for women with postpartum depression approved by FDA

August 7, 2023
Research 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 …

News
eye2

Astellas announces FDA approval for Izervay for GA treatment

August 7, 2023
Medical 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 …

News

FDA approves Merck’s Ervebo vaccine for under 18s

August 4, 2023
Research 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. …

News

FDA approves Taiho’s Lonsurf for metastatic colorectal cancer treatment

August 3, 2023
Medical 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 …

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Chemotherapy

FDA grants ODD to ABM Therapeutics’ treatment for patients with glioblastoma

August 3, 2023
Medical 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. …

News

GSK’s Jemperli approved for treatment of endometrial cancer

August 1, 2023
Research 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 …

News

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FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

September 22, 2023

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan performs well in phase 3 trial

September 22, 2023

Novo Nordisk partners with UNICEF to prevent global childhood obesity

September 21, 2023

EC approves Menarini Group’s Orserdu for breast cancer treatment

September 21, 2023

Pharmanovia acquires CNS portfolio from Sanofi

September 20, 2023