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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Tag: FDA
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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FDA OK’s third dose of Moderna’s COVID-19 vaccine for immunocompromised
Recent trial showed improved immune response after third dose
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Tecentriq wins FDA priority review for certain early NSCLC patients
Tecentriq is first and only cancer immunotherapy with positive Phase III results in adjuvant lung cancer setting
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AZ, Amgen’s asthma med tezepelumab gains FDA priority review
Priority review comes following positive results from the Phase III NAVIGATOR trial
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- Acoramidis approved for heart condition treatment
- Genomics study launches to optimise childhood cancer care in Ireland
- UCL researchers launch congenital muscular dystrophy research programme
- Novavax shares positive real-world results for JN.1-adapted COVID-19 vaccine
- FDA approves Click’s digital therapeutic for episodic migraine
