Tag: FDA Approved

FDA Approved Xenleta to Treat Adults with Community-Acquired Bacterial Pneumonia

The U.S. Food and Drug Administration approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. “This new drug provides another option for the treatment of patients wi...

FDA Approved Celgene INREBIC for Myelofibrosis Treatment

Celgene Corporation announced the U.S. Food and Drug Administration (FDA) has approved INREBIC® (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (...

FDA Approved AbbVie Janus Kinase Inhibitor

AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) i...

FDA Approved First Spinal Tether Device to Treat Children with Progressive Idiopathic Scoliosis

The U.S. Food and Drug Administration approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis,...

FDA Approved Barostim Neo System for Improvement of Symptoms in Patients with Advanced Heart Failure...

The U.S. Food and Drug Administration approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure...

FDA Approved Genentech’s Rozlytrek

The U.S. Food and Drug Administration granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neuro...

FDA Approved WAKIX® for the Treatment of Excessive Daytime Sleepiness

Harmony Biosciences, LLC announced that the U.S. Food and Drug Administration approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WA...

FDA Approved Pretomanid Tablets for Treatment of Highly Treatment-Resistant Lungs’ TB

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

FDA Approved Regeneron’s EYLEA®

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA® (...

FDA Approved Generic Version of Hygroton Tablets

Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure.  The company has received abbreviated new drug...

FDA Granted Approval to Daiichi Sankyo’s Turalio

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 seve...

New Monotherapy Indication for Merck’s KEYTRUDA® Approved by FDA

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment ...

FDA Approved Bayer’s Non-Steroidal Androgen Receptor Inhibitor

The U.S. Food and Drug Administration (FDA) has approved darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa®. The FDA approval is for the treatment of pati...

FDA Cleared for Marketing Four Cleared Tests to Aid in the Diagnosis of Lyme Disease

The U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared now are the first time that a ...

FDA Approved Shield Therapeutics’ Lead Product Feraccru®

Shield Therapeutics, a commercial-stage, a pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product ...

Shanghai and Changzhou WuXi STA Facilities Passed FDA Inspections

Pharmaceutical company WuXi STA has announced that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou have...