Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1410 posts found.

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
volodymyr-hryshchenko-m1hq4ibp9rc-unsplash

Janssen submits sNDA to FDA for full approval of Balversa

August 29, 2023
Research and Development Balversa, FDA, Janssen, Oncology

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to …

News
robina-weermeijer-ihfopazzjhm-unsplash_5

FDA approves Sandoz’s Tyruko biosimilar to treat relapsing forms of MS

August 25, 2023
Medical Communications FDA, MS, Neurology, Sandoz

Novartis’ Sandoz has announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by …

News

Tarsus Pharmaceuticals’ Xdemvy approved by FDA for treatment of Demodex blepharitis

August 25, 2023
Medical Communications Demodex blepharitis, FDA, Opthalmology, Tarsus Pharmaceuticals, eyedrops

Tarsus Pharmaceuticals has announced that the US Food and Drug Administration (FDA) approved its drug Xdemvy (lotillaner ophthalmic solution) 0.25% …

News
hal-gatewood-_jbclosdsd4-unsplash

FDA grants ODD to NXC-201 as multiple myeloma treatment

August 24, 2023
Medical Communications FDA, Nexcella, ODD, Oncology, multiple myeloma

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

News

FDA approves Pfizer’s vaccine for the prevention of RSV in children

August 22, 2023
Research and Development FDA, Paediatrics, Pfizer, RSV

On Monday, Pfizer announced that the US Food and Drug Administration (FDA) has approved Abrysvo for the prevention of respiratory …

News

FDA approves first ever treatment for rare CHAPLE disease

August 21, 2023
Research and Development CHAPLE disease, FDA, Rare Diseases, rare disease

The US Food and Drug Administration (FDA) has approved Regeneron’s Veopoz (pozelimab), a new treatment for CHAPLE disease for both …

News

FDA approves IMIDEX’s AI-powered device VisiRad XR

August 18, 2023
Research and Development FDA, Radiology, pharma, radiology

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug Administration (FDA) for its artificial …

News

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

Latest content

FDA approves Amgen’s Imdelltra for extensive-stage small cell lung cancer

May 17, 2024

AstraZeneca shares results from phase 3 trial of COVID-19 prevention drug

May 17, 2024

GSK pledges £45m to Fleming Initiative to fight AMR

May 16, 2024

NeuroSense partners with PhaseV on upcoming phase 3 ALS trial

May 16, 2024

AstraZeneca adds new heart failure target through collaboration with BenevolentAI

May 15, 2024