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RSS FeedPosted by Michael Wonder on 02 May 2024
Amolyt Pharma granted FDA fast track designation for eneboparatide for the treatment of hypoparathyroidism
2 May 2024 - Amolyt Pharma today announced that eneboparatide, its lead therapeutic peptide candidate in Phase 3 development for the ...
Posted by Michael Wonder on 02 May 2024
Labcorp receives FDA approval for first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with haemophilia B
29 April 2024 - Labcorp today announced the U.S. FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to ...
Posted by Michael Wonder on 02 May 2024
US FDA approves high concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira
1 May 2024 - Boehringer Ingelheim announced today that the US FDA has approved the high concentration, citrate-free formulation of ...
Posted by Michael Wonder on 02 May 2024
Neurocrine Biosciences announces US FDA approval of Ingrezza Sprinkle (valbenazine) capsules
30 April 2024 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral ...
Posted by Michael Wonder on 01 May 2024
Iterum Therapeutics resubmits new drug application to US FDA for oral sulopenem
29 April 2024 - Potential approval early Q4, 2024. ...
Posted by Michael Wonder on 01 May 2024
Aquestive Therapeutics receives US FDA approval and market access for Libervant (diazepam) buccal film in paediatric patients ages 2 to 5
29 April 2024 - Announces immediate availability of Libervant 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg for ...
Posted by Michael Wonder on 01 May 2024
Bavarian Nordic initiates rolling submission of biologics license application with FDA for its Chikungunya vaccine candidate
29 April 2024 - Bavarian Nordic today announced that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 01 May 2024
Eton Pharmaceuticals announces submission to FDA of new drug application for ET-400 (hydrocortisone oral solution)
30 April 2024 - Company anticipates 10 month review for potential approval in Q1, 2025. ...
Posted by Michael Wonder on 30 Apr 2024
Dermavant announces FDA acceptance of supplemental new drug application for Vtama (tapinarof) 1% cream for the treatment of atopic dermatitis in adults and children 2 years of age and older
29 April 2024 - FDA PDUFA action expected in Q4, 2024. ...
Posted by Michael Wonder on 29 Apr 2024
Soleno Therapeutics receives breakthrough therapy designation from US FDA for diazoxide choline extended release tablets in Prader-Willi syndrome
29 April 2024 - Designation is based on data from the Phase 3 program for diazoxide choline. ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves first drug for WHIM syndrome, a rare disorder that can lead to recurrent, life threatening infections
29 April 2024 - The US FDA has approved Xolremdi (mavorixafor) capsules in patients 12 years of age and older with ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
29 April 2024 - Today, the FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen) for recurrent or metastatic cervical ...
Posted by Michael Wonder on 29 Apr 2024
Celltrion USA signs agreement with Express Scripts for its therapy for autoimmune diseases including the first FDA approved subcutaneous infliximab Zymfentra
28 April 2024 - Celltrion USA announced today that it has signed an agreement with Express Scripts, one of the nation's ...
Posted by Michael Wonder on 27 Apr 2024
Use evidence to support early coverage of gene therapy after accelerated approval
23 April 2024 - Gene editing and therapy to replace missing or defective genes is one of the most exciting ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...