Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB

FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema

Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control

FDA lifts hold on Rocket Pharma's gene therapy trial

Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort

Novo Nordisk's Wegovy approved in the US for the treatment of MASH

The accelerated approval is supported by results from part 1 of the ESSENCE trial

FDA approves first immunotherapy for recurrent respiratory papillomatosis

Tonix receives FDA approval of Tonmya for treatment of fibromyalgia

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp