Jazz gets US FDA orphan drug exclusivity for Xywav to treat idiopathic hypersomnia
The US FDA has recognised seven years of ODE for Xywav in June 2021 to treat cataplexy or…
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04 Jan 22
The US FDA has recognised seven years of ODE for Xywav in June 2021 to treat cataplexy or…
03 Jan 22
The company has submitted the chemistry, manufacturing and controls (CMC) data module, completing final data packages required for…
03 Jan 22
The FDA approval was supported by positive results from Phase 3 SONICS and LOGICS studies evaluating Recorlev in…
30 Dec 21
Eplontersen is an investigational ligand-conjugated antisense (LICA) medicine, designed to treat all types of TTR amyloidosis (ATTR)
29 Dec 21
The Drugs Controller General of India (DCGI) has also granted emergency use approval for Biological E’s Covid-19 vaccine…
28 Dec 21
Keytruda plus Lenvima combination is currently approved in Japan, the US and Europe to treat certain advanced endometrial…
27 Dec 21
Covaxin was already approved by India’s Central Drugs Standards Control Organisation (CDSCO) for restricted use in an emergency…
24 Dec 21
The US regulator’s approval is based on the Phase 3 MOVe-OUT trial, which assessed molnupiravir 800 mg twice-daily…
24 Dec 21
Under the expanded agreement, SK bioscience will reserve additional manufacturing capacity to produce antigen, a key component of…
23 Dec 21
The US regulator’s decision is based on the data from the Phase 2/3 EPIC-HR trial, which enrolled non-hospitalised…