Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1407 posts found.

AstraZeneca’s sBLA for FluMist Quadrivalent accepted by FDA

October 24, 2023
Medical Communications AstraZeneca, FDA, FluMist, Immunology, flu vaccine, sBLA

AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Agreement …

News

FDA accepts Sun Pharma’s NDA for deuruxolitinib

October 6, 2023
Medical Communications Dermatology, FDA, NDA, SUun Pharma, deuruxolitinib

India-based pharma company Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has accepted its New …

News

FDA grants marketing authorisation to DNA test for predisposition to certain cancers

October 2, 2023
Research and Development FDA, Invitae, Oncology, cancer testing, oncology

The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the Invitae Common Hereditary Cancers Panel, …

News

Biogen’s biosimilar Tofidence approved by FDA

October 2, 2023
Medical Communications Actemra, Biogen, FDA, Musculo-skeletal disorder, Tofidence

Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) as an intravenous formulation, a …

News
robina-weermeijer-so1l3jsdd3y-unsplash_2

Karuna Therapeutics submits NDA to FDA for schizophrenia treatment

September 29, 2023
Medical Communications FDA, Karuna Therapeutics, Neurology, mental health, schizophrenia

Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration …

News

Regeneron and Sanofi’s sBLA for Dupixent accepted by FDA for priority review

September 26, 2023
Medical Communications Dupixent, Ear Nose & throat, FDA, Regeneron, Sanofi

Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has accepted their supplemental Biologics License …

News

FDA approves Eli Lilly and Boehringer Ingelheim’s Jardiance for chronic kidney disease treatment

September 25, 2023
Medical Communications Boehringer Ingelheim, Eli Lilly, FDA, Nephrology, chronic kidney disease

Eli Lilly and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10mg …

News

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

September 22, 2023
Medical Communications FDA, Haematology, Nexcella, amyloidosis

Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to NXC-201 for …

News

GSK’s Ojjaara approved by FDA for patients with myelofibrosis and anaemia

September 18, 2023
Medical Communications FDA, GSK, Haematology, Ojjaara, anaemia, myelofibrosis

GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate …

News

Madrigal Pharmaceuticals’ NDA for resmetirom accepted by FDA

September 14, 2023
Medical Communications FDA, Internal Medicine, Madrigal Pharma, nash, resmetirom

Madrigal Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application …

News

FDA approves LimFlow system for patients with CLTI

September 13, 2023
Medical Communications CLTI, Devices, FDA, LimFlow

LimFlow SA has announced that the US Food and Drug Administration (FDA) has approved its LimFlow System for the treatment …

News

BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib

September 7, 2023
Research and Development BridgeBio Pharma, EMA, FDA, Musculo-skeletal disorder, achondroplasia, clinical trial

BridgeBio Pharma has announced positive feedback from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on …

News
hal-gatewood-_jbclosdsd4-unsplash

FDA approves new ADHD and BED generics

September 1, 2023
Medical Communications BED, FDA, Pharmacy, generic medicines

The US Food and Drug Administration (FDA) has announced that it has approved several first generics of Takeda’s Vyvanse (lisdexamfetamine …

News
blood-1813410_960_720

FDA approves BMS’s Reblozyl for treatment of anaemia in adults with lower-risk MDS

August 30, 2023
Research and Development FDA, Haematology, Reblozyl, anaemia, bristol myers squibb, myelodysplastic syndromes

Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the …

News

FDA gives Orphan Drug Designation to Faron Pharmaceuticals’ Bexmarilimab

August 29, 2023
Research and Development FDA, Faron, ODD, Oncology, leukemia

Faron Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its …

News

Latest content

Mirum Pharmaceuticals publishes phase 3 MARCH maralixibat data in The Lancet

May 8, 2024

Circular Genomics reveals study results into predicting patient response to SSRI antidepressant treatment

May 8, 2024

Gossamer Bio and Chiesi Group enter into international collaboration to commercialise Seralutinib

May 7, 2024

Broken String Biosciences and the Francis Crick Institute collaborate on ALS research

May 7, 2024

AbbVie invests €150m in new R&D facility in Germany

May 3, 2024