FDA
FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis
September 22, 2023Medical 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 …
GSK’s Ojjaara approved by FDA for patients with myelofibrosis and anaemia
September 18, 2023Medical 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 …
Madrigal Pharmaceuticals’ NDA for resmetirom accepted by FDA
September 14, 2023Medical 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 …
FDA approves LimFlow system for patients with CLTI
September 13, 2023Medical 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 …
BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib
September 7, 2023Research 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 …
FDA approves new ADHD and BED generics
September 1, 2023Medical 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 …
FDA approves BMS’s Reblozyl for treatment of anaemia in adults with lower-risk MDS
August 30, 2023Research 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 …
FDA gives Orphan Drug Designation to Faron Pharmaceuticals’ Bexmarilimab
August 29, 2023Research 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 …
Janssen submits sNDA to FDA for full approval of Balversa
August 29, 2023Research 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 …
FDA approves Sandoz’s Tyruko biosimilar to treat relapsing forms of MS
August 25, 2023Medical 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 …
Tarsus Pharmaceuticals’ Xdemvy approved by FDA for treatment of Demodex blepharitis
August 25, 2023Medical 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% …
FDA grants ODD to NXC-201 as multiple myeloma treatment
August 24, 2023Medical 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 …
FDA approves Pfizer’s vaccine for the prevention of RSV in children
August 22, 2023Research 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 …
FDA approves first ever treatment for rare CHAPLE disease
August 21, 2023Research 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 …
FDA approves IMIDEX’s AI-powered device VisiRad XR
August 18, 2023Research 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 …
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Five Facts about cardiovascular disease
