Supplemental New Drug Application

Contract Pharma · 4d

Merck’s WELIREG Accepted for Priority Review by FDA for Pheochromocytoma and Paraganglioma

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

Targeted Oncology · 2d

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 set for May 26, 2025.

Cure Today · 2d

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 pheochromocytoma and paraganglioma.

MarketWatch · 4d

Merck Gets FDA Priority Review of Welireg in Rare Adrenal Tumors

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the adrenal glands.

Business Insider · 4d

Merck: FDA grants priority review to sNDA for Welireg

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s

Seeking Alpha · 3d

Merck gets priority review for Welireg for PPGL

The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare type of adrenal gland tumors. Read more here.

40mon MSN

Here’s Summers Value Partners’ Investment Thesis for Indivior (INDV)

Summers Value Partners, an investment management company, released its fourth quarter 2024 investor letter. A copy of the ...

Zacks.com on MSN8d

J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy Use

Johnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for ...

Medscape6d

FDA OKs Esketamine Nasal Spray Monotherapy for Resistant Depression

The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not ...

Managed Healthcare Executive7d

FDA and EMA Accepts Applications for New Nusinersen Regimen

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...

Healio8d

FDA approves Spravato as monotherapy for adults with major depressive disorder

The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...

Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA

Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...

Pharmabiz1h

Renalys Pharma completes patient enrollment in registrational phase III trial of sparsentan for IgA nephropathy in Japan

Renalys Pharma completes patient enrollment in registrational phase III trial of sparsentan for IgA nephropathy in Japan: Tokyo, Japan Friday, January 31, 2025, 18:00 Hrs [IST] Re ...

PharmaTimes3d

FDA approves new Alzheimer’s treatment regimen

The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once ...

Monthly Prescribing Reference3d

Belzutifan Gets Priority Review for Advanced Pheochromocytoma and Paraganglioma

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

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