Zydus Therapeutics New Drug Application (NDA) for Saroglitazar to Treat Primary Biliary Cholangitis (PBC) Granted Priority Review by the US FDA

Дата публикации: 28-05-2026 04:05:31

PENNINGTON, N.J. and AHMEDABAD, India, May 28, 2026 /PRNewswire/ -- Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Limited, a global innovation-led health care company, today announced that the US Food and Drug Administration...

Схожие новости

#	Наименование новости	Тональность	Информативность	Дата публикации
1	U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations	0	11.68	28-04-2026
2	U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir	0	14.72	29-04-2026
3	Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD	0	15.69	28-05-2026
4	Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST	0	10.76	28-05-2026
5	Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer	0	14.56	22-07-2026
6	Saol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by the FDA with PDUFA Date of Dec. 30, 2026	0	15.84	28-07-2026
7	Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)	0	12.6	30-06-2026
8	Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)	0	17.8	26-05-2026
9	Saol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD), an Ultra-Rare Disease	0	12.73	07-07-2026
10	FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting	0	11.63	01-06-2026

Классификация: Пресс-релизы. Схожих патентов: 0. Схожих новостей: 10. Тональность: 0. Информативность: 11.94. Источник: www.drugs.com.