Pfizer’s Litfulo approved in Europe to treat severe alopecia areata

By NS Healthcare Staff Writer

20 Sep 23

Litfulo works by irreversibly and selectively inhibiting JAK3 and the TEC family of kinases by blocking γ-common cytokine…

PharmaceuticalsRegulation

ViiV Healthcare receives EC approval for Apretude to prevent HIV

By NS Healthcare Staff Writer

19 Sep 23

Cabotegravir is approved for use in combination with safer sex practices as a pre-exposure prophylaxis (PrEP) method and…

PharmaceuticalsRegulation

US FDA approves Pfizer-BioNTech, Moderna’s updated Covid-19 vaccines

By NS Healthcare Staff Writer

12 Sep 23

Pfizer and BioNTech’s updated Covid-19 vaccine, Comirnaty 2023-2024, and Moderna’s Spikevax were indicated for people aged 12 years…

PharmaceuticalsRegulation

EC grants additional indication to Merck’s Ervebo to include children aged one and older

By NS Healthcare Staff Writer

08 Sep 23

Ervebo is a live recombinant viral vaccine that has a VSV backbone removed for the VSV envelope glycoprotein…

PharmaceuticalsRegulation

Mallinckrodt launches Lisdexamfetamine Dimesylate Capsules for ADHD after FDA approval

By NS Healthcare Staff Writer

01 Sep 23

The FDA has approved the firm’s ANDA for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and…

PharmaceuticalsRegulation

Janssen files sNDA to FDA for Balversa full approval in mUC treatment

By NS Healthcare Staff Writer

29 Aug 23

The sNDA filing was based on the data from Cohort 1 of the late-stage THOR trial in which…

PharmaceuticalsRegulation

AstraZeneca’s Soliris granted expanded approval in Japan to treat children with gMG

By NS Healthcare Staff Writer

25 Aug 23

Japan’s MHLW expands Soliris’ indication to include children who are anti-acetylcholine receptor (AChR) antibody-positive, for whom high-dose intravenous…

PharmaceuticalsRegulation

EC clears Pfizer’s ABRYSVO vaccine to protect infants and older adults from RSV

By NS Healthcare Staff Writer

25 Aug 23

The marketing authorisation was based on the findings of the MATISSE and RENOIR clinical trials and follows a…

PharmaceuticalsRegulation

US FDA grants priority review for Pfizer, Astellas’ prostate cancer drug Xtandi

By NS Healthcare Staff Writer

24 Aug 23

FDA accepted Pfizer and Astellas’ supplemental New Drug Application (sNDA) for Xtandi, expanding its indication to include patients…

PharmaceuticalsRegulation

US FDA approves Pfizer’s Abrysvo vaccine to prevent RSV-related disease in infants

By NS Healthcare Staff Writer

22 Aug 23

Abrysvo, a bivalent RSV prefusion F (RSVpreF) vaccine that contains two preF proteins to optimise the protection against…

PharmaceuticalsRegulation