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Tuesday, April 16, 2024
FDA | Pharmtech Focus

FDA

About FDA

FDA

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the food supply, cosmetics, and products that emit radiation.

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June 9 2023

Vertex Pharmaceuticals and CRISPR Therapeutics today announced that the United States Food and Drug Administration (FDA) […]

FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

May 24 2023

The U.S. Food and Drug Administration (FDA) has approved Xacduro (sulbactam for injection; durlobactam for […]

FDA Accepts Application for Roche’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

May 9 2023

Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s […]

FDA Grants Accelerated Approval for PADCEV® with KEYTRUDA for First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer

April 4 2023

Seagen and Astellas Pharma have announced the United States Food and Drug Administration (FDA) has […]

FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval

March 27 2023

The United States Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to […]

TrueBinding Granted Type B End-of-Phase 2 Meeting with FDA for Discussion of Accelerated Development Pathway for TB006 Alzheimer's Disease Treatment

March 16 2023

TrueBinding, a clinical-stage biotherapeutic company creating new and exciting molecules for applications in neurodegenerative and […]

Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval

March 13 2023

Pfizer has announced the US Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the […]

FDA Accepts Supplemental New Drug Application for Jardiance® for Children 10 years and Older with Type 2 Diabetes

March 9 2023

The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for […]

FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma

March 6 2023

Aldeyra Therapeutics has announced that the US Food and Drug Administration (FDA) accepted for Priority […]

Reata Pharmaceuticals Announces FDA Approval of SKYCLARYS™ (Omavaloxolone), the First and Only Drug Indicated for Patients with Friedreich’s Ataxia

March 1 2023

Reata Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing novel therapies for patients with […]

Pfizer Receives Potential FDA Approval for RSV Vaccine Candidate

March 1 2023

Pfizer has announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological […]

Chiesi Global Rare Diseases Announces FDA Approval of Lamzede®(velmanase alfa-tycv) for Alpha-Mannosidosis

February 17 2023

Chiesi Global Rare Diseases announced today that the US Food and Drug Administration (FDA) has […]

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter

February 13 2023

MCRA, a leading medical device-focused regulatory advisory firm and clinical research organization (CRO) integrating US […]

FDA Approves Pfizer's Supplemental New Drug Application for CIBINQO® (abrocitinib)

February 13 2023

Pfizer has announced that the United States Food and Drug Administration (FDA) approved its supplemental […]

U.S. FDA Grants Regular Approval for Jemperli for the Treatment of Patients with Recurrent or Advanced Mismatch Repair-deficient Endometrial Cancer

February 10 2023

GSK reports that the US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) […]

FDA Grants Regenerative Medicine Advanced Therapy Designation for Rexlemestrocel-L in Chronic Low Back Pain

February 9 2023

Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the […]

Sandoz Biologics License Application for Proposed Biosimilar Denosumab Accepted by US FDA

February 6 2023

Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US […]

Egret Therapeutics Receives FDA Clearance of IND Application for EGT 101 for Treatment of Delayed Cerebral Ischemia

February 6 2023

Egret Therapeutics, a clinical-stage biotechnology company focused on developing transformative therapies for neurological conditions, has […]

Jesduvroq Approved by US FDA for Anaemia of Chronic Kidney Disease in Adults on Dialysis

February 2 2023

GSK today announced that the US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat), […]

Genoscience Pharma receives FDA Orphan Drug Designation for ezurpimtrostat to treat HepatoCellular Carcinoma (HCC)

February 1 2023

Genoscience Pharma, a clinical-stage biotech company developing unique lysosomotropic drug candidates for the treatment of […]

Ionis receives FDA Fast Track designation for Olezarsen in patients with Familial Chylomicronemia Syndrome

January 31 2023

Ionis Pharmaceuticals today announced that the United States Food and Drug Administration (FDA) has granted […]

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Higher-Risk Myelodysplastic Syndrome

January 26 2023

Syros Pharmaceuticals, a biopharmaceutical company committed to advancing new standards of care for the frontline […]

US FDA Accepts Supplemental New Drug Application for Jardiance® for Adults with Chronic Kidney Disease

January 20 2023

The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) […]

Evaxion Receives FDA Fast-track Designation for Personalized Cancer Immunotherapy

January 20 2023

Evaxion Biotech A/S, a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, today […]

FDA Accepts GMP Plasmid DMF of OBiO Technology

January 17 2023

OBiO Technology, a gene and cell therapy-focused contract research organization (CRO) and contract development and […]

Jnana Therapeutics Announces FDA Clearance of IND Application for JNT-517 for the Treatment of Phenylketonuria

January 6 2023

Jnana Therapeutics, a biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug […]

U.S. FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Inaccessible Brain Tumors

January 3 2023

Datar Cancer Genetics has announced that the US Food and Drug Administration (FDA) has granted […]

Click Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Episodic Migraine

December 16 2022

Click Therapeutics, a leader in Digital Therapeutics™ as prescription medical treatments, has announced today that […]

FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes

November 22 2022

The U.S. Food and Drug Administration (FDA) has approved Tzield (teplizumab-mzwv), an injection to delay […]

FDA Approves Roche’s Evrysdi for Use in Babies Under Two Months With Spinal Muscular Atrophy (SMA)

May 31 2022

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration […]

FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

May 23 2022

Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) […]

FDA Approves NGS-Based Companion Diagnostic for EGFR Exon20 Insertion Mutant Non-Small Cell Lung Cancer Tumor Tissue

December 10 2021

The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific‘s Oncomine Dx Target […]

FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

October 11 2021

Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients […]

Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older

August 24 2021

Pfizer Inc.and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) approved […]

Tezepelumab Regulatory Submission Accepted and Granted FDA Priority Review in the US for the Treatment of Patients with Asthma

July 8 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for […]

FDA Approval of Aducanumab

June 10 2021

Neurimmune welcomes the news that the U.S. Food and Drug Administration (FDA) has approved Biogen‘s […]

U.S. FDA Approves Prevnar 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

June 9 2021

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved […]

AskBio Announces IND for LION-101 Cleared to Proceed by U.S. FDA

May 26 2021

Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced that […]

Pink Luminous Breast (PLB) Takes Steps Toward FDA Class III Approval

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Pink Luminous Breast (PLB) is continuing to make strides in breast cancer awareness with a new […]

Amgen Tezepelumab BLA Submitted to U.S. FDA

May 11 2021

Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to […]

Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents

May 11 2021

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food […]

Pfizer and BioNTech Initiate BLA for FDA Approval of Vaccine

May 10 2021

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application […]

Viome Receives FDA Approval for its Unique mRNA Technology and AI Platform to Detect Cancers

May 10 2021

Viome, a mission-driven bioscience company focused on helping individuals improve their health, today announced its […]

FDA Accepts Amgen's sNDA For Otezla ®

May 6 2021

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for […]

ViiV Healthcare New Drug Application for Long-Acting Cabotegravir for Prevention of HIV

May 4 2021

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer […]

FDA Grants Accelerated Approval for GSK’s JEMPERLI (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer

April 23 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has […]

U.S. FDA Approves NEXTSTELLIS ®, New Oral Contraceptive

April 19 2021

Mayne Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved NEXTSTELLIS […]

RETINA-AI Health Awarded U.S. Patent for AI Eye Disease Detection

April 19 2021

RETINA-AI Health Inc. has been awarded a U.S. patent on its Artificial Intelligence (AI) systems […]

FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

April 13 2021

Today, the U.S. Food and Drug Administration (FDA) authorized marketing of the GI Genius, the […]

FDA approves new treatment for adults with relapsed or refractory large-b-cell lymphoma

February 10 2021

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy […]

FDA approves first extended-release, injectable drug regimen for adults living with HIV

January 21 2021

The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as […]

FDA statement on following the authorized dosing schedules for COVID-19 vaccines

January 6 2021

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 […]