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Showing 15 posts of 1442 posts found.

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
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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
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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
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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
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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
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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
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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
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