FDA | PharmaTimes

FDA approves Click’s digital therapeutic for episodic migraine

Emily Kimber — Thu, 17 Apr 2025 10:40:03 +0000

More than 37 million adults in the US are affected by migraine

FDA approves Deciphera’s Romvimza for rare tumour type

Emily Kimber — Thu, 20 Feb 2025 12:23:56 +0000

Tenosynovial giant cell tumours can cause pain, stiffness, swelling and movement limitations

FDA approves ANDA of 20mg generic Nitisinone capsules

Jen Brogan — Thu, 01 Jun 2023 12:10:00 +0000

Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine

FDA grants fast-track designation for Istesso’s IPF candidate

John Pinching — Mon, 05 Dec 2022 12:57:00 +0000

The therapy has reduced inflammation and supported the remodelling of damaged bone

GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

Fleur Jeffries — Mon, 31 Oct 2022 13:14:00 +0000

A final decision for daprodustat by the FDA is expected by 1 February 2023

Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial

Fleur Jeffries — Mon, 22 Aug 2022 11:37:00 +0000

Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy

New drug application accepted by FDA for GSK’s momelotinib

John Pinching — Thu, 18 Aug 2022 11:45:00 +0000

Therapy for the treatment of myelofibrosis has received significant results from phase 3 trial

FDA approves Exelixis’ Cabometyx for differentiated thyroid cancer

Lucy Parsons — Tue, 21 Sep 2021 09:16:00 +0000

Cabometyx found to reduce the risk of disease progression or death versus placebo in this patient population

Accelerated FDA approval for GSK’s Jemperli

Lucy Parsons — Wed, 18 Aug 2021 11:29:00 +0000

Indicated for the treatment of of dMMR recurrent or advanced solid tumours

FDA OK’s third dose of Moderna’s COVID-19 vaccine for immunocompromised

Lucy Parsons — Mon, 16 Aug 2021 10:12:00 +0000

Recent trial showed improved immune response after third dose