to developing innovative therapies for rare dermatologic conditions, announced that the U.S. Food and Drug Administration (FDA) has responded to its Investigational New Drug (IND) application for its lead investigational product candidate, ARK001,...
Dr. Oregonin Inc. announced that it has completed U.S. Food and Drug Administration (FDA) registration for OLTIS DENTAL-X, paving the way for its official commercial entry into the North American oral-care market. The product's authorization...
17 products manufactured under the international guidance have been approved by the U.S. Food and Drug Administration (FDA) alone. Developed jointly with GEA, the ConsiGma® CDC Flex platform also incorporates SimpleCT, a suite of automation and...
research through clinical applications. The company operates under an ISO 13485:2016-certified quality system, with an FDA-registered manufacturing facility and research and development operations in Colorado. CaseBioscience also partners with...
animal health company, announced the launch of Florfinasone Otic (florfenicol, terbinafine, mometasone furoate), an FDA-approved product indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia...
Engineer, Pharma & Device Testing. Eric brings over 20 years of industry experience, and a proven track record leading FDA registered, cGMP compliant labs. Eric's deep expertise in pharmaceutical test standards and established industry...
This research collaboration builds on that work and reflects Ro and Novo's shared commitment to expanding access to FDA-approved treatment while using real-world evidence to continually improve the care experience for patients. "Working with Novo,...
certain mailed goods subject to other federal agencies' requirements, including those of the Food and Drug Administration (FDA). The Wall Street Journal reported Sept. 22 that patients ordering lower-cost prescriptions from foreign mail-order...
Merck known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg, based on the Phase 3...
and infusion-related reactions. VYEPTI® (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing...
multiple sclerosis, depression and more. The development of the N2B New Approach Methodologies (NAM), consistent with FDA’s support for these approaches, aims to enable screening compounds that are amenable for N2B delivery, supporting safer...
Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards. Cyclophosphamide for Injection, USP had U.S. sales of approximately $133 million for...
are often used for convenience, especially in those late-night hours when mixing formula is less than ideal. However, both FDA and CDC advise parents of infants under two months of age and those with weakened immune systems should also consider...
announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking Accelerated Approval for XPOVIO® (selinexor) in combination with ruxolitinib for patients with myelofibrosis....
Abbott the global healthcare leader, today announced U.S. Food and Drug Administration (FDA) authorization of its Libre Duo 10 Day system, the world's first dual glucose‑ketone sensing technology. The new biowearable is designed to alert people...
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive...
neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic...
the largest integrated health system in the U.S. serving nine million enrolled veterans annually. Proliv Rx received FDA approval in December 2025 as the first and only prescription at-home brain neuromodulation therapy for adults with MDD who have...
Merck known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for ENFLONSIA™ (clesrovimab-cfor) to expand its indication to...
Takeda announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent...
