FDA Approvals
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Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration granted approval for Sunosi, a treatment for people with narcolepsy.
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FDA approves new device for treating moderate to severe chronic heart failure in patients
3/21/2019
The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat.
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Enzyvant's Investigational Farber Disease Enzyme Replacement Therapy, RVT-801, Receives FDA Fast Track and Rare Pediatric Disease Designations
3/21/2019
Enzyvant, a biopharmaceutical company focused on developing and commercializing transformative therapies for patients with rare diseases, today announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease and Fast Track designations for RVT-801, an investigational enzyme replacement therapy.
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Beckman Coulter's Compact, Low-volume Hematology Analyzer Receives FDA 510(k) Clearance
3/21/2019
With just 17 microliters of blood, the DxH 520 enables low-volume laboratories to deliver 5-part differential test results in 60 seconds or less
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The approval of Zulresso marks the first and only treatment for postpartum depression (PPD) approved by the U.S. Food and Drug Administration.
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Hitachi Chemical Diagnostics, Inc. Receives FDA 510(k) Clearance for OPTIGEN® AP 3600TM, an advan...
3/20/2019
Hitachi Chemical Diagnostics, Inc., a global leader in multiplex allergy in vitro diagnostics, announced today that it received 510 clearance from the U.S Food and Drug Administration for its new high capacity allergy testing instrument, OPTIGEN® AP 3600TM. -
Motif Bio Granted Meeting with U.S. FDA regarding Iclaprim
3/20/2019
The meeting is scheduled to take place on May 3, 2019.
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WuXi Biologics Receives EMA GMP Certificates
3/20/2019
WuXi Biologics to be the first biologics company in China approved by both the U.S. FDA and EMA
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Jazz Pharmaceuticals Announces U.S. FDA Approval of Sunosi™ (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
3/20/2019
Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
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This approval marks the first new initial treatment option for this difficult-to-treat type of lung cancer in more than 20 years.
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FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
3/19/2019
Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
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Sage Therapeutics Announces FDA Approval of ZULRESSO™ (brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression
3/19/2019
Postpartum depression is the most common medical complication of childbirth, estimated to affect approximately 400,000 women annually in the U.S.
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FDA approves first treatment for postpartum depression
3/19/2019
The U.S. Food and Drug Administration approved Zulresso injection for intravenous use for the treatment of postpartum depression in adult women.
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It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.
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Takeda Receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
3/18/2019
FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient
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U.S. FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut Allergy
3/18/2019
Aimmune Therapeutics, Inc. announced that the Biologics License Application (BLA) for AR101 has been accepted for review by the U.S. Food and Drug Administration (FDA).
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Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients
3/18/2019
Label Now Includes New Data on Use of AVYCAZ for Treatment of cUTI and cIAI in Pediatric Patients 3 Months of Age and Older
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Aptar Pharma’s Bidose Nasal Drug Delivery Device Approved by U.S. FDA for Breakthrough Treatment of Depression
3/18/2019
Aptar Pharma, a leading drug delivery systems provider, is pleased to announce that its Bidose nasal spray device was recently approved by the U.S. FDA for a breakthrough therapy in the field of depression.
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Zyppah® Anti-Snoring Device Awarded First "Dual Action" Over-The-Counter 510k Clearance from the Food & Drug Administration
3/18/2019
Zyppah® retails for $99.95 and is available on Zyppah.com and Amazon.com.
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Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
3/18/2019
Systemic sclerosis (SSc), also known as scleroderma, is a rare chronic connective tissue disease