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.
Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announced it had official discussions with the FDA on a detailed plan for a phase 1/2 clinical trial to start developing a new treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric disease, using its proprietary drug, OKN-007.
V2ACT Therapeutics™, LLC is a joint venture of Genelux Corporation and TVAX Biomedical, Inc.
Phase 3 TETON study planned in 2021 for Tyvaso® in patients with idiopathic pulmonary fibrosis
The Michael J. Fox Foundation for Parkinson's Research (MJFF) has received the Advocacy/Policy Award from the Reagan-Udall Foundation for the Food and Drug Administration.
The National Kidney Foundation presents "Voice of the Patient Report: IgA Nephropathy" to federal agency
CorVent Medical, a Coridea portfolio company focused on developing versatile, reusable, lifesaving ventilators, announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for primary critical care use of the company's RESPOND-19™ Ventilator.
Eurofins announces that its FDA-authorized At-Home COVID-19 Nasal PCR Test is now being covered by Medicare, Medicaid and commercial insurance providers.
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
Company eligible to receive Priority Review Voucher upon FDA approval of ACN00177
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 has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
The U.S. Food and Drug Administration (FDA) has cleared StrokeViewer LVO, NICO.LAB's artificial intelligence powered solution in stroke care
BrainEver, a biotechnology company dedicated to the research and development of innovative therapies for the treatment of neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its product BREN-02
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
