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Showing 15 posts of 1442 posts found.

Qfitlia approved by FDA to treat haemophilia A or B

March 31, 2025
Research 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 …

News

FDA grants fast track designation to chlamydia vaccine candidate

March 28, 2025
Research 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 …

News

Prenatal care could be revolutionised suggests studies from BrightHeart

January 31, 2025
Research 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 …

News

NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera

January 29, 2025
Sales 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 …

News

NMD Pharma’s Charcot-Marie-Tooth disease treatment granted ODD by FDA

January 6, 2025
CMT, 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 …

News

J&J seek approval for first drug to treat high-risk smoldering myeloma

November 13, 2024
Research 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 …

News
nasal-spray-drawing

First Nasal Spray for Treatment of Anaphylaxis approved by FDA

August 12, 2024
Research 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, …

News

FDA release statement exercising caution around dosing errors associated with compounded injectable semaglutide products

July 31, 2024
Media 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 …

News

BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin

July 25, 2024
Medical 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, …

News

FDA accepts Atara Biotherapeutics’ Tab-Cel for priority review

July 18, 2024
Medical 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 …

News

FDA approves AbbVie’s Skyrizi for UC treatment

June 20, 2024
Medical 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 …

News

FDA approves Merck’s Capvaxive for prevention of pneumococcal disease

June 18, 2024
Medical 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) …

News
robina-weermeijer-ihfopazzjhm-unsplash_5

FDA accepts Eisai’s Leqembi sBLA for early AD treatment

June 11, 2024
Medical Communications Alzheimer's, Biogen, FDA, Neurology, sBLA

Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted Eisai’s supplemental biologics license application …

News

GSK’s Arexvy vaccine approved by FDA for RSV prevention in adult patients

June 10, 2024
Medical Communications FDA, GSK, Immunology, Vaccine

GSK has announced that the US Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) …

News
yunus-tug-lnfgdbcajxu-unsplash

FDA approves Geron’s Rytelo for treatment of MDS with transfusion-dependent anaemia

June 7, 2024
Medical Communications FDA, Geron, Haematology, anaemia, mds

Geron Corporation has announced that the US Food and Drug Administration (FDA) has approved Rytelo (imetelstat) for the treatment of …

News
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