Pfizer’s JAK1 inhibitor Cibinqo approved in US to treat atopic dermatitis

By NS Healthcare Staff Writer

17 Jan 22

Cibinqo is an oral, once-daily, oral small molecule that selectively inhibits Janus kinase 1 (JAK1), to modulate multiple…

PharmaceuticalsRegulation

Gilead withdraws cancer drug Zydelig to treat NHL and SLL

By NS Healthcare Staff Writer

17 Jan 22

Zydelig will be continued as a treatment for CLL and FL in the European Union (EU), the UK,…

PharmaceuticalsRegulation

Novavax’ protein-based Covid-19 vaccine approved in South Korea

By NS Healthcare Staff Writer

13 Jan 22

Nuvaxovid, Novavax’ recombinant, adjuvanted Covid-19 vaccine, is the first protein-based Covid-19 shot to get regulatory approval in South…

PharmaceuticalsRegulation

AbbVie gets FDA breakthrough therapy designation for Teliso-V to treat NSCLC

By NS Healthcare Staff Writer

05 Jan 22

The breakthrough therapy designation was granted based on data from LUMINOSITY, an ongoing Phase 2 study structured to…

PharmaceuticalsRegulation

US FDA expands EUA for Comirnaty booster to include 12- to 15-year-olds

By NS Healthcare Staff Writer

04 Jan 22

The FDA also expanded the EUA to include a third primary series dose for children aged five to…

PharmaceuticalsRegulation

Jazz gets US FDA orphan drug exclusivity for Xywav to treat idiopathic hypersomnia

By NS Healthcare Staff Writer

04 Jan 22

The US FDA has recognised seven years of ODE for Xywav in June 2021 to treat cataplexy or…

PharmaceuticalsRegulation

Novavax submits final data to seek FDA EUA for Covid-19 vaccine

By NS Healthcare Staff Writer

03 Jan 22

The company has submitted the chemistry, manufacturing and controls (CMC) data module, completing final data packages required for…

PharmaceuticalsRegulation

Xeris gets US FDA approval for Recorlev to treat Cushing’s syndrome

By NS Healthcare Staff Writer

03 Jan 22

The FDA approval was supported by positive results from Phase 3 SONICS and LOGICS studies evaluating Recorlev in…

PharmaceuticalsRegulation

Novavax, Serum Institute gets emergency use authorisation for Covovax in India

By NS Healthcare Staff Writer

29 Dec 21

The Drugs Controller General of India (DCGI) has also granted emergency use approval for Biological E’s Covid-19 vaccine…

PharmaceuticalsRegulation

Keytruda plus Lenvima approved in Japan to treat advanced uterine cancer

By NS Healthcare Staff Writer

28 Dec 21

Keytruda plus Lenvima combination is currently approved in Japan, the US and Europe to treat certain advanced endometrial…

PharmaceuticalsRegulation