En Carta Diagnostics’ EC Pocket Lyme test receives FDA Breakthrough Device Designation
The US sees around 476,000 new Lyme cases every year
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Tag: FDA
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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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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- Kahimmune Therapeutics enters licensing agreement with Gustave Roussy and SATT Paris-Saclay
- IBSA UK&I launches Perovial for the treatment of acute Peyronie’s disease
- En Carta Diagnostics’ EC Pocket Lyme test receives FDA Breakthrough Device Designation
- ALK’s EURneffy receives positive CHMP opinion for emergency anaphylaxis treatment in children
- CERo reports encouraging early data from phase 1 trial of CER‑1236
