Lilly, Novo Nordisk closer to deal with Trump administration to slash obesity drug prices to $149/month

The discussions come as part of the administration’s broader efforts to drive down drug prices and increase patient access to essential therapies

FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency

Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion

FDA approves first immunotherapy for recurrent respiratory papillomatosis

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

First and only TROP2-directed therapy approved in the US for the treatment of lung cancer