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.

Latest

17 Nov, 2023, 15:19 GMT The European Commission Approves Label Update for TAKHZYRO® (lanadelumab), Expanding Its Use to a Broader Group of Paediatric Patients with Recurrent Attacks of Hereditary Angioedema (HAE)

Takeda (TSE:4502/NYSE:TAK) today announced the European Commission has approved TAKHZYRO® (lanadelumab) for the routine prevention of recurrent...

16 Nov, 2023, 16:00 GMT Kanna Health announces FDA and MHRA approvals to begin its Phase 1 clinical trial for the development of KH-001 as first FDA-approved treatment for premature ejaculation

The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Kanna Health's...

16 Nov, 2023, 09:05 GMT Versameb AG Announces FDA Clearance of IND Application for VMB-100 in the Treatment of Stress Urinary Incontinence

Versameb AG ("Versameb"), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that...

10 Nov, 2023, 12:48 GMT Rznomics Inc. Secures Fast Track Designation from the U.S. FDA for RZ-001

Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, announced today that it...

08 Nov, 2023, 13:13 GMT Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and...

02 Nov, 2023, 13:51 GMT Empatica's Platform Receives New FDA Clearance for Cardiac Digital Biomarkers

Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today...

31 Oct, 2023, 12:52 GMT U.S. FDA AWARDS BOTH RARE PEDIATRIC DISEASE AND ORPHAN DRUG DESIGNATIONS TO HG204, A CRISPR RNA-EDITING THERAPY, FOR THE TREATMENT OF MECP2 DUPLICATION SYNDROME

HuidaGene Therapeutics (辉大基因，"HuidaGene"), a global clinical-stage biotechnology company focused on developing CRISPR-based programmable genomic...

24 Oct, 2023, 07:17 GMT Clinical Trial Application (IND) for BioRay Pharmaceutical's BR105 Injection Receives U.S. FDA Approval

BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced on October 7th that its clinical trial application for BR105...

23 Oct, 2023, 13:50 GMT Fighting the Silent Killer: Innovative Therapies for Pancreatic Cancer on the Rise

USA News Group - Despite being a relatively rare form of cancer, pancreatic cancer remains one of the deadliest in the oncology field, the third...

23 Oct, 2023, 13:30 GMT Certa Therapeutics' FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis

Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases,...

04 Oct, 2023, 18:15 GMT U.S. FDA GRANTS LIPOGEMS® SECOND IDE APPROVAL FOR A CLINICAL TRIAL ON THE TREATMENT FOR KNEE OA

The U. S. Food and Drug Administration (FDA) has awarded Lipogems another Investigational Device Exemption (IDE) study for the use of MicroFat for...

03 Oct, 2023, 20:14 GMT Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that the Novavax...

02 Oct, 2023, 11:15 GMT Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Enable Injections, Inc. ("Enable") today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for...

02 Oct, 2023, 00:30 GMT WuXi Biologics Congratulates Amicus Therapeutics on U.S. FDA Approval for New Treatment for Pompe Disease

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its...

27 Sep, 2023, 17:35 GMT Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has ...

18 Sep, 2023, 10:30 GMT Crown Aesthetics Announces Launch Expansion of BIOJUVE™ Living Skin Biome Care into the United Kingdom, Ireland, and Germany

Crown Aesthetics ("Crown"), a division of Crown Laboratories, Inc., is excited to announce the launch of its newest innovation, BIOJUVE™, in the...

13 Sep, 2023, 13:00 GMT Wave of FDA Fast Track Designations Highlight Biotech Momentum Carrying into 2023

USA News Group - Sufferers of many different ailments saw reason to grow their hope in 2022 when the US Food and Drug Administration (FDA) granted...

23 Aug, 2023, 10:03 GMT Trisol announces successful implants of its Transcatheter Tricuspid Valve in the US

The heart teams at the Piedmont Heart Institute in Atlanta, Georgia, USA and the University of Virginia Health System in Charlottesville, VA, USA,...

18 Aug, 2023, 08:21 GMT FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT), (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) ...

16 Aug, 2023, 18:15 GMT Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval

HELSINGBORG, Sweden, Aug. 16, 2023 /PRNewswire/ – Today, Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of...

15 Aug, 2023, 08:00 GMT Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China

Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and...

10 Aug, 2023, 13:28 GMT Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough ...

07 Aug, 2023, 12:15 GMT HUIDAGENE THERAPEUTICS RECEIVES FDA RARE PEDIATRIC DISEASE DESIGNATION FOR HG004 TO TREAT INHERITED BLINDNESS

HuidaGene Therapeutics (辉大基因，"HuidaGene"), a clinical-stage biotechnology company focused on developing CRISPR-based programmable genomic medicines,...

31 Jul, 2023, 16:59 GMT FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure...

26 Jul, 2023, 13:00 GMT CartiHeal Announces First Commercial Implantation of Agili-C™ in the US

CartiHeal Ltd., developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, today...

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