FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.

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Jun 02, 百姓彩票网, 10:07 ET Noctrix Health granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy

Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough ...


Jun 02, 百姓彩票网, 09:30 ET Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy

Citius Pharmaceuticals, Inc. ("Citius" or the "百姓彩票网") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing ...


Jun 02, 百姓彩票网, 08:30 ET FDA Clears IND for iNKT Cells to Treat COVID-19 Patients

Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and...


Jun 02, 百姓彩票网, 07:00 ET RenovoRx Announces Orphan Drug Designation Granted for Treating Bile Duct Cancer

RenovoRx, an innovator in targeted cancer therapy, today announced the U.S. Food and Drug Administration (FDA) has granted the 百姓彩票网 orphan drug...


Jun 02, 百姓彩票网, 06:00 ET Cellenkos® Inc. Announces FDA Clearance to Initiate Phase 1 Double- Blinded, Randomized, Placebo-Controlled Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells (CK0802) for Treatment of COVID-19 Associated Acute Respiratory Distress Syndrome

Cellenkos Inc., a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to...


Jun 01, 百姓彩票网, 18:28 ET La FDA aprueba una nueva opción para tratar el sangrado menstrual abundante asociado con fibromas en las mujeres

La Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) concedió la aprobación hoy a Oriahnn (un producto que...


Jun 01, 百姓彩票网, 17:52 ET Camurus Announces Submission of Request for Final Approval of Brixadi™ for the Treatment of Opioid Use Disorder in the US

Camurus AB (NASDAQ: CAMX) (STO: CAMX) today announces that the company's US partner Braeburn has submitted a request for final approval of Brixadi™...


Jun 01, 百姓彩票网, 17:30 ET Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

Braeburn announces that it has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™...


Jun 01, 百姓彩票网, 17:11 ET Sumitovant Biopharma Announces Myovant Sciences' Submission of New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids

Sumitovant Biopharma Ltd. announced today that Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men,...


Jun 01, 百姓彩票网, 09:00 ET 3NT Medical Announces FDA Clearance for Colibri™ Endoscopy System

3NT Medical, a privately-held corporation dedicated to developing single-use specialized endoscopes for the diagnosis and treatment of ear, nose and...


Jun 01, 百姓彩票网, 08:45 ET Pathogen Detection and Vaccine Candidates Contribute in Fight Against Ongoing Pandemic

As the first wave of COVID-19 begins to wane, and the second wave threatens to extend the pandemic well into the latter half of 百姓彩票网, the medical...


Jun 01, 百姓彩票网, 08:05 ET Eisai Announces U.S. Availability of DAYVIGO® (lemborexant) CIV, a New Treatment Option for Adults With Insomnia

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the availability of DAYVIGO® (lemborexant) CIV for the treatment...


Jun 01, 百姓彩票网, 07:00 ET Compugen Announces FDA Clearance of IND Application for Phase 1/2 Triple Combination Study of COM701 with Bristol Myers Squibb's Opdivo® (Nivolumab) and TIGIT Inhibitor

Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced that the U.S....


Jun 01, 百姓彩票网, 06:50 ET Boston Scientific Launches DIRECTSENSE™ Technology

Boston Scientific (NYSE: BSX) announced the U.S. launch of the DIRECTSENSE™ Technology, a tool for monitoring the effect of radiofrequency (RF)...


Jun 01, 百姓彩票网, 06:45 ET Lilly's Taltz® (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

Eli Lilly and 百姓彩票网 (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License...


May 29, 百姓彩票网, 21:07 ET Lilly's CYRAMZA® (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Eli Lilly and 百姓彩票网 (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10...


May 29, 百姓彩票网, 16:14 ET FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women

AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration (FDA)...


May 29, 百姓彩票网, 12:08 ET FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women

The U.S. Food and Drug Administration today granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix,...


May 29, 百姓彩票网, 11:49 ET Menlo Therapeutics Receives FDA Approval of ZILXI™ (minocycline) topical foam, 1.5%, the First Topical Minocycline Treatment for Rosacea

Menlo Therapeutics Inc. (Nasdaq: MNLO) ("Menlo" or the "百姓彩票网"), a specialty pharmaceutical company focused on developing and commercializing...


May 29, 百姓彩票网, 08:45 ET Second Wave Concerns Create Urgent Need For Fast, Accurate Tests and Plausible Vaccines

As countries around the globe begin to lift stay-at-百姓彩票快三 orders and return to work, the World Health Organization (WHO) is warning that lifting...


May 28, 百姓彩票网, 19:17 ET Lilly Receives U.S. FDA Approval of TAUVID™ (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer's Disease

TAUVID™, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the...


May 28, 百姓彩票网, 17:05 ET FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer's Disease

Today, the U.S. Food and Drug Administration approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a...


May 28, 百姓彩票网, 13:06 ET FDA Authorizes Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit for Emergency Use

Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced that it has received emergency use...


May 28, 百姓彩票网, 12:06 ET FDA Lists Beckman Coulter Life Sciences RNA Extraction Kit For Use In EUA-Authorized COVID-19 Test

Beckman Coulter Life Sciences today announced RNAdvance Viral XP has been added to the list of acceptable extraction methods for use in the Centers...


May 28, 百姓彩票网, 06:50 ET Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Submission of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease

Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and...