FDA Approvals
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Found 12,979 articles
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FDA approves new treatment for patients with migraine
10/11/2019
The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.
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EicOsis Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain
10/10/2019
Phase 1 clinical trials for their drug candidate, EC5026, for the treatment of pain.
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Glaukos Achieves Pipeline Milestone with Completion of Patient Enrollment in U.S. IDE Trial for iStent infinite™
10/10/2019
Company Completes Enrollment of Subjects in Trial Designed to Evaluate Safety and Performance of Its Three-Stent System in Standalone Procedure for Advanced Glaucoma
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Scenesse is an under-the-skin implant. The drug is the company’s only approved product.
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VirTrial Awarded FDA-Approved Decentralized Clinical Trial with Hope Biosciences
10/9/2019
Study protocol incorporates remote visits via VirTrial’s telehealth platform.
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Beckman Coulter's DxA 5000 total laboratory automation solution receives U.S. FDA 510(k) clearance
10/9/2019
Research shows errors that occur in the pre-analytical phase of testing may contribute up to 75% of erroneous test results, with 26% possibly having an adverse effect on patient care.
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Novartis' Wet AMD Drug Wins FDA Approval
10/8/2019
The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Novartis' drug demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity at 48 weeks. -
FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder
10/8/2019
The U.S. Food and Drug Administration today approved Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria.
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FDA Approves Octapharma’s WILATE® for Hemophilia A in Adult and Adolescent Patients
10/8/2019
Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.
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Dexcom Announces FDA Clearance of New Dexcom G6 Pro CGM
10/8/2019
First and only single-use, professional CGM system with blinded or unblinded mode
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Aethlon Medical Announces FDA Approval Of IDE For Oncology Indications
10/7/2019
Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in global health, announced today that the FDA has approved its Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the Company's proprietary Hemopurifier® in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda).
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The only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
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The approval was based on data from the Phase III GRECO clinical trial and the Phase I AMES trial.
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Galderma Receives FDA Approval for AKLIEF® (trifarotene) Cream, 0.005%, the First New Retinoid Molecule for the Treatment of Acne in Over 20 Years
10/4/2019
Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne.
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FASENRA® (benralizumab) Approved in the US for Self-administration in a New Pre-filled Auto-injector, the FASENRA Pen™
10/4/2019
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of FASENRA® (benralizumab) in a pre-filled, single-use auto-injector (the FASENRA Pen™).
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Immunexpress Announces Closing of Private Funding Round
10/3/2019
Funding will support the development of SeptiCyte™ RAPID through FDA 510(k) Clearance
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FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
10/3/2019
The U.S. Food and Drug Administration approved Descovy in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
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U.S. Food and Drug Administration Approves Descovy® for HIV Pre-Exposure Prophylaxis (PrEP)
10/3/2019
Descovy Demonstrated Non-inferior Efficacy and an Improved Bone and Renal Safety Profile Compared with Truvada® in People at Risk for Sexually Acquired HIV Infection in a Global Phase 3 Trial
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Agilent Receives Approval for First PD-L1 Companion Diagnostic in China
10/2/2019
Agilent Technologies Inc. (NYSE: A) today announced that the National Medical Products Administration (NMPA, formerly the China Food and Drug Administration) has approved its PD-L1 IHC 22C3 pharmDx assay for use in China.
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FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
10/2/2019
Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.