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.
Priority Review Vouchers subject to approved NDA
Company eligible to receive Priority Review Voucher upon FDA approval of ACN00177
Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation
Once-daily treatment with GAVRETO demonstrated robust efficacy in patients with RET-altered thyroid cancers, including prolonged duration of response
Eurofins announces that its FDA-authorized At-Home COVID-19 Nasal PCR Test is now being covered by Medicare, Medicaid and commercial insurance providers.
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.
The National Kidney Foundation presents "Voice of the Patient Report: IgA Nephropathy" to federal agency
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.
Phase 3 TETON study planned in 2021 for Tyvaso® in patients with idiopathic pulmonary fibrosis
V2ACT Therapeutics™, LLC is a joint venture of Genelux Corporation and TVAX Biomedical, Inc.
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.
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.
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.
Test is authorized for individuals two years of age or older, including those not showing symptoms
The U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.
Agency Urges Online Marketplaces, Other Websites and Retailers to Stop Selling These Male Enhancement and Weight Loss Products to American Consumers
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for AYVAKIT™ (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (SM).
Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells™.
