GEMTESA® is the second FDA approval for the Sumitovant Biopharma family of companies in the past weekGEMTESA® is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant Sciences
Bracco Diagnostics Inc., the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration (FDA) has approved ProHance® (Gadoteridol) Injection, 279.3 mg/mL for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years old, including term neonates, to visualize areas with disrupted blood brain barrier and/or abnormal vascularity throughout the brain, spine and associated tissues.
GEMTESA is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant Sciences
Shenyang Tonglian Group Co., Ltd. announces FDA approval for a randomized, multicenter, placebo-controlled, double-blind clinical study of the safety and efficacy of Carrimycin for the treatment of severe COVID-19 in hospitalized patients
The Lupus Research Alliance (LRA) congratulates GSK on the U.S. Food and Drug Administration (FDA) approval of belimumab (Benlysta®) as the first-ever treatment indicated specifically for adults with lupus nephritis (LN), a complication of systemic lupus erythematosus (SLE).
The U.S. Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations.
IND Approval Marks Key Step in Beginning of Potentially Pivotal Trial of Berubicin
MSN Labs, based in Hyderabad India, recently received FDA approval to market their generic versions of Toremifene 60mg tablets, (AB rated to Kyowa Kirin's Fareston©) & Aminocaproic Acid 500mg tablet, (AB rated Clover's Amicar©) under the Novadoz label.
The leaders of 18 pharmacy organizations today issued the following statement following the Food and Drug Administration's approval of the first Emergency use Authorization for the COVID-19 vaccine.
Once-daily treatment with GAVRETO demonstrated robust efficacy in patients with RET-altered thyroid cancers, including prolonged duration of response
Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation
Priority Review Vouchers subject to approved NDA
The U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
The U.S. Food and Drug Administration (FDA) has cleared StrokeViewer LVO, NICO.LAB's artificial intelligence powered solution in stroke care
The Progeria Research Foundation and Eiger BioPharmaceuticals Celebrate Historic Milestone with FDA Approval of Zokinvy™ (lonafarnib) for the Treatment of Progeria and Processing-Deficient Progeroid Laminopathies
Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function
The U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu.