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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08:30 ET Theravance Biopharma Highlights Approval of Expanded Indication in the US for Once-Daily Trelegy Ellipta for Treatment of COPD Patients

Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today highlighted that the US Food and Drug Administration (FDA) has approved an...


08:05 ET FDA Approval of ThinPrep® Integrated Imager Expands Automated Imaging for Pap Testing to More Labs

Hologic, Inc. (Nasdaq: HOLX) announced today that the United States Food and Drug Administration (FDA) has granted premarket approval (PMA) for the...


07:30 ET Mylan Adds to Growing Women's Healthcare Portfolio with Launch of Generic for Oral Contraceptive Yaz®

Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02...


Apr 24, 2018, 17:19 ET JYNARQUE™ Approved as First Treatment for Polycystic Kidney Disease

The PKD Foundation is excited to announce that on April 24 the U.S. Food and Drug Administration (FDA) granted approval of JYNARQUE™...


Apr 24, 2018, 16:02 ET Kindred Biosciences Provides Updates on Pending Drug Approvals

Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has...


Apr 24, 2018, 10:10 ET Lin BioScience Announces FDA Orphan Drug Designation for LBS-007 for the Treatment of Acute Lymphoblastic Leukemia

Lin BioScience, a drug development company targeting unmet clinical needs in oncology, ophthalmology and metabolic diseases, announced today that...


Apr 24, 2018, 08:00 ET Quotient Limited Announces FDA Approval of Seven Blood Bank Reagents, Including Two Market Firsts

Quotient Limited ("Quotient") (NASDAQ: QTNT), an established, commercial-stage diagnostics company, today announced the recent FDA approval for...


Apr 23, 2018, 20:11 ET FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA)...


Apr 23, 2018, 09:00 ET Viz.ai Receives FDA Clearance for Automated Computed Tomography Perfusion (CTP) Software

Viz.ai, Inc., an applied artificial intelligence healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has cleared...


Apr 20, 2018, 08:15 ET Varian Calypso Anchored Beacon Transponder for Lung Receives FDA 510k Clearance

Varian (NYSE: VAR) today announced it has received FDA 510(k) clearance for its Calypso® Anchored Beacon® transponder. Used with a Varian...


Apr 20, 2018, 08:14 ET FDA Accepts Veloxis's Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR®

Veloxis Pharmaceuticals A/S announced today that the U.S. Food & Drug Administration (FDA) has accepted for standard review the Company's...


Apr 19, 2018, 05:00 ET OBI Pharma Announces FDA Clearance of OBI-3424 IND Application for A Phase I/II Study Targeting AKR1C3 Solid Tumors

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has cleared an...


Apr 19, 2018, 05:00 ET OBI Pharma erhält FDA-Genehmigung für IND-Antrag auf Phase-I/II-Studie zu OBI-3424 bei AKR1C3-exprimierenden soliden Tumoren

Erste klinische Studie zur Prüfung der Sicherheit und Wirksamkeit eines neuartigen zielgerichteten First-in-Class-Therapeutikums (kleinmolekulares...


Apr 19, 2018, 05:00 ET OBI Pharma annonce l'approbation par la FDA de sa demande de DNR pour une étude de phase I/II de l'OBI-3424 dans le traitement des tumeurs solides exprimant l'enzyme AKR1C3

Première étude clinique testant la sécurité et l'efficacité d'une thérapie ciblée innovante (promédicament à petites molécules) qui libère de...


Apr 18, 2018, 19:17 ET Roche expands indication for cobas® EGFR Mutation Test v2 as a companion diagnostic with TAGRISSO®

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its...


Apr 18, 2018, 19:06 ET US FDA Approves TAGRISSO® (osimertinib) As 1st-Line Treatment For EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for the 1st-line treatment of...


Apr 18, 2018, 17:37 ET Arthrosurface Gains FDA Clearance of OVOMotion™ Shoulder Arthroplasty System

Arthrosurface® announced today that The Company received FDA 510(k) Clearance to market the OVOMotion™ Shoulder Arthroplasty System. This stemless...


Apr 18, 2018, 09:00 ET Cantel Medical Receives FDA 510(k) Clearance to Market ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor

Cantel Medical Corp. (NYSE: CMD) announced today that it has received U.S. Food and Drug Administration (FDA) 510 (k) clearance for its ADVANTAGE...


Apr 18, 2018, 08:30 ET ANI Pharmaceuticals Announces Approval of Morphine Sulfate Oral Solution

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration ("FDA")...


Apr 18, 2018, 03:36 ET NeuroVive's KL1333 Receives FDA Orphan Drug Designation for Treatment of Mitochondrial Diseases

NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF), the mitochondrial medicine company, today announced that it has been granted...


Apr 17, 2018, 16:51 ET Rigel Announces FDA Approval of TAVALISSE™ (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia (ITP) in Adult Patients

Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved TAVALISSE™ (fostamatinib...


Apr 17, 2018, 13:28 ET FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia

The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and...


Apr 17, 2018, 08:00 ET FDA Provides Full Approval to Praxbind, Specific Reversal Agent for Pradaxa

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind® (idarucizumab), the...


Apr 17, 2018, 07:00 ET King-Devick technologies receives FDA clearance for K-D Balance™ App

King-Devick technologies, inc., a leading provider of evidence- based assessment tools, today announced it has received 510(k) clearance from the...


Apr 16, 2018, 17:00 ET Zimmer Biomet Announces FDA Clearance and First Surgical Case of the Persona® Trabecular Metal™ Tibia

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the completion of the first...