FDA
Thermosome secures FDA Orphan Drug Designation for soft tissue sarcoma therapy
May 12, 2025Research and Development European Medicines Agency (EMA), FDA, Oncology, Thermosome
Thermosome has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its lead candidate, THE001, …
Genmab to submit FDA application for lymphoma therapy
May 2, 2025Research and Development AbbVie, Biologics License Application, FDA, Genmab, Oncology, epcoritamab, lymphoma, therapeutics
Global biotechnology company Genmab plans to submit a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) …
Mursla Bio’s platform for surveillance of liver cancer receives FDA approval
April 24, 2025Industry Associations, Research and Development BDD, FDA, Mursla Bio, Oncology, hepatocellular carcinoma (HCC), liver disease
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to EvoLiver, Mursla Bio’s surveillance platform for …
Qfitlia approved by FDA to treat haemophilia A or B
March 31, 2025Research and Development FDA, Haematology, Sanofi, haemophilia, pharma
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran) as the first therapy in the US to treat …
FDA grants fast track designation to chlamydia vaccine candidate
March 28, 2025Research and Development FDA, Infections and infestations, Sanofi, chlamydia, vaccination
The US Food and Drug Association (FDA) has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention …
Prenatal care could be revolutionised suggests studies from BrightHeart
January 31, 2025Research and Development AI, BrightHeart, FDA, Obstetrics & Gynaecology, prenatal, studies
Private medical device and artificial intelligence (AI)-led company, BrightHeart, has revealed two studies which show an improvement to pre-natal care …
NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera
January 29, 2025Sales and Marketing Duchenne Muscular Dystrophy, EC, EMA, FDA, Santhera Pharmaceuticals, positive
Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to …
NMD Pharma’s Charcot-Marie-Tooth disease treatment granted ODD by FDA
January 6, 2025CMT, FDA, NMD Pharma, Orphan Drugs, Pain, nervous system, research and development
Biotech company NMD Pharma has announced that the US Food and Drug Association (FDA) have granted its Charcot-Marie-Tooth (CMT) disease …
J&J seek approval for first drug to treat high-risk smoldering myeloma
November 13, 2024Research and Development FDA, J&J, Rare Diseases, bone marrow
Earlier in November, Johnson & Johnson innovative medicine have applied to the US Food and Drug Agency (FDA) and the …
First Nasal Spray for Treatment of Anaphylaxis approved by FDA
August 12, 2024Research and Development Emergency Medicine, FDA, anaphylaxis, epinephrine, nasal
ARS Pharmaceuticals has been granted approval by the US Food and Drug Administration (FDA) for their epinephrine nasal spray, neffy, …
FDA release statement exercising caution around dosing errors associated with compounded injectable semaglutide products
July 31, 2024Media Relations, Medical Communications, Pharmacovigilance, US Healthcare & Trade Press FDA, Gastrointestinal tract, compunded injectable, dosage, hospitalisation, pharmaceutical, warning
This week, the US Food and Drug Administration (FDA) and have issued warnings regarding dosing errors associated with compounded injectable …
BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin
July 25, 2024Medical Communications BioAtla, FDA, Oncology, fast track designation, ozuriftamab vedotin
BioAtla has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, …
FDA accepts Atara Biotherapeutics’ Tab-Cel for priority review
July 18, 2024Medical Communications Atara Biotherapeutics, FDA, Virology, priority review
Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License …
FDA approves AbbVie’s Skyrizi for UC treatment
June 20, 2024Medical Communications AbbVie, FDA, Gastrointestinal tract, UC, ibd
AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adult …
FDA approves Merck’s Capvaxive for prevention of pneumococcal disease
June 18, 2024Medical Communications Capvaxive, FDA, Infections and infestations, Merck, pneumonia
Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) …
