Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™) has been granted Orphan Drug Designation[1] (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treament of Chemotherapy-Induced Thrombocytopenia (CIT).
PDUFA date set for July 19, 2020. If approved, QUTENZA would be the first topical treatment with a TRPV1 agonist indicated for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
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First Tazarotene Acne Treatment Approved in Lotion Formulation
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The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.
Amgen's Fourth FDA Approval From Biosimilars Portfolio
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LT1001 (brand name Naldebain®) is a prodrug of nalbuphine, an abuse-free analgesic that has been marketed worldwide for decades.
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Acceptance of the IND application will allow the company to begin Phase I clinical trials for SKL24741 in 2020
The U.S. Food and Drug Administration approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).
XCOPRI is approved for the treatment of partial-onset seizures in adult patients
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices
The future of imaging is here—and FDA cleared.
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients
VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability
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Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years.
Approval Marks 11th BOTOX® Therapeutic Indication and Comes 30 Years After the First Indications Were Approved
The highly anticipated approval of Beovu® (brolucizumab) may reduce the frequency of intravitreal injections for wet age-related macular degeneration patients following clinical trials at Wolfe Eye Clinic
The U.S. Food and Drug Administration (FDA) has approved AMZEEQTM (minocycline) topical foam, 4 percent. Manufactured by Foamix Pharmaceuticals Ltd., AMZEEQ, formerly known as FMX101, is the first topical minocycline to be approved by the FDA for any condition.