FDA Approvals
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Inspire Medical Systems, Inc. Announces FDA Approval of Expanded, Full-Body MRI Compatibility with Inspire Therapy
7/6/2022
Inspire Medical Systems, Inc. today announced that the United States Food and Drug Administration (FDA) has approved additional magnetic resonance imaging (MRI) scan conditions for use with Inspire therapy.
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US FDA AWARDS RARE PEDIATRIC DISEASE DESIGNATION (RPDD) TO PAXALISIB FOR AT/RT, A RARE FORM OF CHILDHOOD BRAIN CANCER
7/6/2022
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia's paxalisib for the treatment of atypical rhabdoid / teratoid tumors (AT/RT).
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InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum
7/6/2022
InflaRx N.V. today announced that the US Food and Drug Administration (FDA) granted a Fast Track designation o the development of its first-in-class anti-C5a monoclonal antibody vilobelimab for the treatment of ulcerative pyoderma gangrenosum (PG).
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Pyramid Biosciences Receives Orphan Drug Designation for PBI-200 From FDA
7/6/2022
Pyramid Biosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for PBI-200, a next-generation, highly brain penetrant inhibitor of the neurotrophic tyrosine receptor kinase (NTRK) currently in clinical development for the treatment of NTRK fusion-positive solid tumors.
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FDA Approves Sientra’s Low Plus Profile Projection Breast Implant
7/6/2022
Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) approved the Low Plus Profile Projection Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction.
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As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
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Titan Pharmaceuticals Announces FDA Clearance of IND Application for Nalmefene Implant
7/5/2022
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") application for a Phase 1 study of its six-month or longer subdermal formulation of nalmefene.
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Ra Medical Systems Receives FDA 510(k) Clearance for the DABRA 2.0 Catheter
7/5/2022
Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company”), a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces receipt of U.S. Food and Drug Administration 510(k) clearance for the Company’s DABRA 2.0 catheter.
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Nurix Therapeutics Announces Clearance of Investigational New Drug Application For NX-1607 Supporting Plans to Expand Enrollment to U.S. Clinical Sites
6/30/2022
Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company's Investigational New Drug (IND) application to expand the ongoing Phase 1 clinical program for NX-1607 into sites in the United States.
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Phanes Therapeutics' PT886 granted Orphan Drug Designation for the treatment of pancreatic cancer by the FDA
6/30/2022
Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT886 for the treatment of pancreatic cancer.
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Aura Biosciences Receives FDA Fast Track Designation for Belzupacap Sarotalocan (AU-011) for the Treatment of Non-Muscle Invasive Bladder Cancer
6/30/2022
Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for belzupacap sarotalocan (AU-011), Aura’s first VDC product candidate, for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).
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INSIGHTEC RECEIVES FDA IDE APPROVAL FOR PROSTATE CANCER COMPARATIVE STUDY USING HIGH INTENSITY FOCUSED ULTRASOUND TECHNOLOGY
6/30/2022
nsightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it has received FDA approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate Prostate system used to treat diseased prostate tissue.
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Achieve Life Sciences Announces Initiation of Phase 2 ORCA-V1 Clinical Trial Evaluating Cytisinicline for Nicotine e-cigarette Cessation
6/29/2022
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced it has initiated screening of subjects for the ORCA-V1 Phase 2 clinical trial.
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Elite Pharmaceuticals Receives FDA Approval for Generic Sabril(R)
6/29/2022
Elite Pharmaceuticals, Inc. announced that it received approval from the US Food and Drug Administration for an Abbreviated New Drug Application for a generic version of Sabril® 500 mg powder for solution packet.
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Beyond Air’s LungFit® PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure
6/28/2022
Beyond Air, Inc. (NASDAQ: XAIR), today announced that the U.S. Food and Drug Administration (FDA) has approved LungFit® PH to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN) (prescription use only).
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Apnimed Granted FDA Fast Track Designation for AD109, a Novel First-in-Class Oral Pharmacologic Combination for the Treatment of Obstructive Sleep Apnea (OSA)
6/28/2022
Apnimed Granted FDA Fast Track Designation for AD109, a Novel First-in-Class Oral Pharmacologic Combination for the Treatment of Obstructive Sleep Apnea (OSA).
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RENUVION® DERMAL HANDPIECE FOR WRINKLE-REDUCTION PROCEDURES CLEARED BY FDA
6/28/2022
Revolutionary Apyx Medical Device Used by Top Physicians in the US Now Available to Patients for Nonsurgical Facial Renewal.
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Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Synthetic Hypericin in the Treatment of Psoriasis
6/28/2022
Soligenix, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial.
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Schrödinger Announces FDA Clearance of Investigational New Drug Application for SGR-1505, a MALT1 Inhibitor
6/28/2022
Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, today announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for its MALT1 inhibitor, SGR-1505.
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BMS’ CAR-T therapy Breyanzi picked up a second approval from the FDA. The cancer drug was approved for the treatment of adult patients with large B-cell lymphoma.