FDA grants Breakthrough Therapy Designation to lung cancer therapy
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to...
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Tag: FDA
FDA approves UroGen’s Zusduri to treat recurrent bladder cancer
Approximately 59,000 LG-IR-NMIBC patients experience recurrent disease every year in the US
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FDA approves Amneal’s self-administered migraine drug Brekiya
Brekiya is now the first DHE auto-injector to be approved by the regulator
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FDA approves Click’s digital therapeutic for episodic migraine
More than 37 million adults in the US are affected by migraine
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FDA approves Deciphera’s Romvimza for rare tumour type
Tenosynovial giant cell tumours can cause pain, stiffness, swelling and movement limitations
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FDA approves ANDA of 20mg generic Nitisinone capsules
Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine
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FDA grants fast-track designation for Istesso’s IPF candidate
The therapy has reduced inflammation and supported the remodelling of damaged bone
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GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis
A final decision for daprodustat by the FDA is expected by 1 February 2023
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Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial
Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy
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New drug application accepted by FDA for GSK’s momelotinib
Therapy for the treatment of myelofibrosis has received significant results from phase 3 trial
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FDA approves Exelixis’ Cabometyx for differentiated thyroid cancer
Cabometyx found to reduce the risk of disease progression or death versus placebo in this patient population
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Accelerated FDA approval for GSK’s Jemperli
Indicated for the treatment of of dMMR recurrent or advanced solid tumours
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- ErVimmune raises 17m euros in funding to develop cancer vaccine
- Book your tickets and join the PM Society for the 40th PM Awards on 20 March 2026
- Sun Pharma’s Unloxcyt now available in US for advanced cutaneous squamous cell carcinoma
- Venner Shipley announces opening of new Bristol office
- AAX Biotech and Vascurie announce new neuro-oncology collaboration
