Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria

The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines

EU to withdraw Levamisole medicines over risk of rare, deadly brain disorder

The recommendation is based on new data from continuous safety monitoring of medicines in the EU

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

STADA & Bio-Thera bag European nod for Gotenfia

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors

Richter’s FYLREVY to transform menopause care in Europe?

The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients

Akums bags key EU GMP certifications for 2 Haridwar plants

Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms

EMA hits record high in vet medicine nods for second year running

EMA recommended 30 veterinary medicines for marketing authorisation in 2025

EMA and FDA unveil joint AI principles to transform drug revelopment

Experts caution that realizing AI’s potential requires careful management and risk mitigation