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

Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial

According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension

FDA approves first immunotherapy for recurrent respiratory papillomatosis

Sarepta advances siRNA collaboration and sale of arrowhead equity investment

Sarepta has also entered into an agreement with Arrowhead to transfer 2,660,989 shares of Arrowhead common stock in satisfaction of $50 million of the company’s previously announced $100 million milestone payment obligation

Pfizer’s sickle cell disease candidate fails Phase III trial

Inclacumab was generally well tolerated in THRIVE-131

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

European Commission grants approval of Ogsiveo

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors

Indoco Remedies receives final USFDA approval for rivaroxaban tablets

Rivaroxaban is used to treat venous thromboembolism

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