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111 News Found

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug
Drug Approval | December 17, 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients


US District Court grants summary judgement in Favour of SPARC for Sezaby PRV
News | December 03, 2025

US District Court grants summary judgement in Favour of SPARC for Sezaby PRV

FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'


Lilly, Novo Nordisk closer to deal with Trump administration to slash obesity drug prices to $149/month
News | November 07, 2025

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
Drug Approval | November 06, 2025

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
Drug Approval | October 29, 2025

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


Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment
News | September 24, 2025

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