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123 News Found

Chugai’s Tecentriq gets green light in Japan for hard-to-treat Thymic Carcinoma
Drug Approval | December 27, 2025

Chugai’s Tecentriq gets green light in Japan for hard-to-treat Thymic Carcinoma

The drug had previously received orphan drug designation for this rare cancer on March 31, 2025


Hansa Biopharma submits FDA application for kidney transplant desensitization treatment
News | December 24, 2025

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant


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