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Pharmaceutical Technology
9 天
FDA review designations: tracking 40 years of innovation
This rising trend mirrors the evolution of the pharmaceutical industry in terms of investment and utilisation of novel ...
Targeted Oncology
2 天
FDA Grants Belzutifan Priority Review For Advanced Pheochromocytoma and Paraganglioma
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...
Pharm Exec
3 天
FDA Grants Priority Review to Merck’s Welireg for Advanced, Unresectable, or Metastatic ...
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in ...
thecardiologyadvisor.com
2 天
FDA Extends Review of Elamipretide for Barth Syndrome
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
Cure Today
1 天
FDA Accepts sNDA for Welireg in Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
9 天
on MSN
Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...
GlobalData on MSN
3 天
MSD wins FDA priority review for Welireg in rare endocrine cancer
The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...
The Washington Post on MSN
8 天
Trump officials pause health agencies’ communications, citing review
The agencies are charged with making decisions that touch the lives of every American and are the source of crucial ...
Cure Today
7 天
The FDA Accepts a BLA for RP1 Plus Opdivo in Advanced Melanoma
The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...
8 天
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
Endocrinology Advisor
7 天
Plozasiran Under Review for Familial Chylomicronemia Syndrome
The FDA has accepted for review the New Drug Application for plozasiran for the treatment for familial chylomicronemia syndrome.
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