Cipla Patalganga facility gets 6 USFDA observations

The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.

USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial

Enhertu approved in the US as first tumour-agnostic HER2-directed therapy

Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers

Abbott receives FDA approval for TriClip

TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery

UroGen Pharma files patent infringement action against Teva Pharmaceuticals

Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial

Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder

First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+

FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension

WINREVAIR is a breakthrough biologic for this rare, progressive disease

AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer

Combination shows consistent benefit across prespecified post-progression outcomes