Regulatory Affairs News Channel

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of the findings of a joint EMA/FDA analysis comparing decisions on 107 new medicine applications at the two agencies between 2014 and 2016. The study also looked at applications for which the agencies had differing outcomes in terms of type of approval and indication.

FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

The U.S. Food and Drug Administration today approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs.

"The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.

FDA approves first therapy for rare joint tumor

Today, the U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

FDA approves first treatment for severe hypoglycemia that can be administered without an injection

The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Severe hypoglycemia occurs when a patient’s blood sugar levels fall to a level where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat.

FDA approves first generics of Lyrica

On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.

FDA approves new treatment for refractory multiple myeloma

Today, the U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment,

FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord.

Regulatory Affairs News

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

FDA approves first therapy for rare joint tumor

FDA approves first treatment for severe hypoglycemia that can be administered without an injection

FDA approves first generics of Lyrica

FDA approves new treatment for refractory multiple myeloma

FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

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