FDA Approvals
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Found 12,182 articles
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This follows a 2017 rejection by the agency, requesting more data. As Jefferies analyst Michael Yee wrote in a note to clients, Amgen is “back in the game.”
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Tivic Health's ClearUP Sinus Pain Relief Wins Best of CES Award From Gear Diary And Top Picks of CES Award From Techlicious
1/17/2019
ClearUP, a first-in-class bioelectronic treatment, received 510(k) clearance from the FDA earlier this month.
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Omeros Finalizes with FDA Clinical Plan for OMS721 Approval in IgA Nephropathy
1/17/2019
Additional Positive Data Reported from Second Cohort in Phase 2 Trial
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Cystinosis Research Foundation Announces Federal Drug Administration Approval for First Human Clinical Trials
1/17/2019
Approval Granted After Study Reveals Stem Cell Repair in Mice
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Nexus Pharmaceuticals announces FDA approval of Busulfan Injection
1/17/2019
Nexus Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company's AP-rated therapeutic equivalent for Busulfex® 60 mg/10 mL (6 mg/1 mL).
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FDA Accepts Genentech’s Supplemental Biologics License Application for Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
1/17/2019
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq® in combination with Abraxane® and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.
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In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
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Noting that the U.S. Food and Drug Administration (FDA) expects more than 200 investigational new drug applications (INDs) by 2020 per year, many of them cell and gene therapies, the agency issued an outline of new procedures it plans to implement this year.
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FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy
1/16/2019
The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.
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NeoImmuneTech Receives Authorization to Proceed from the FDA for IND Application to Evaluate Hyleukin-7 in Combination with a PD-L1 Inhibitor in Advanced High-Risk Skin Cancers
1/16/2019
The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of Hyleukin-7 in combination with Tecentriq in approximately 80 patients with anti-PD-(L)1 naïve or relapsed/refractory high-risk skin cancers.
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Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
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The FDA approved Cabometyx based on the Phase III CELESTIAL trial that showed the drug provided a statistically significant and clinically meaningful improvement in median overall survival.
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The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration grows more incapable of reviewing some medications for approval.
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Your Feedback Matters! Topics in 2019
1/15/2019
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about. -
New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
1/15/2019
Eisai Co., Ltd. and Purdue Pharma, L.P. announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.
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Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for Fourth Consecutive Year
1/15/2019
FDA’s record-breaking year for approvals affirms high value provided by model-informed drug development
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Hansa Medical AB Provides Regulatory Update for Imlifidase in Kidney Transplantation
1/15/2019
Hansa Medical AB provided an update following the Company's regulatory interactions with the European Medical Agency (EMA) and the U.S. Food and Drug Administration (FDA) for imlifidase in kidney transplantation
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FDA Additionally Clears RAPID™ Imaging Platform for Use in Selecting Acute Stroke Patients for Clot Removal
1/15/2019
Approval Puts RAPID in a Class of Its Own for Diagnosing and Treating Stroke
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TransEnterix Receives FDA 510(k) Clearance for Senhance Ultrasonic System
1/15/2019
Senhance Ultrasonic advanced energy capability broadens potential applicability of Senhance surgery in the United States
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WG Critical Care (WGCC) Expands Portfolio With Unique Product
1/15/2019
WG Critical Care Launches the First and Only FDA Approved Ready-To-Use Calcium Gluconate in Sodium Chloride Injection