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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12 Feb, 2019, 10:48 GMT Calliditas Therapeutics Granted Orphan Drug Designation by the FDA for Primary Biliary Cholangitis

Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation...


07 Feb, 2019, 13:00 GMT Endo Agrees Not To Oppose Additional Stay of FDA Litigation Following Restoration of Government Appropriations

Endo International plc ("Endo") (NASDAQ: ENDP) today announced that the U.S. Food and Drug Administration (the "FDA") has requested a further stay of ...


16 Jan, 2019, 13:00 GMT Therachon is Granted Orphan Drug Designation by US FDA for Apraglutide for the Treatment of Short Bowel Syndrome

Therachon AG ("Therachon"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of innovative...


11 Jan, 2019, 09:34 GMT AWAK Technologies Wearable Peritoneal Dialysis Device Granted Breakthrough Device Designation by the US FDA

AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease,...


08 Jan, 2019, 12:52 GMT Embrace by Empatica Receives First of Its Kind FDA Clearance in Epilepsy for Children

Embrace by Empatica has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in children. Embrace is an epilepsy...


08 Jan, 2019, 12:44 GMT Grifols receives FDA approval of Erytra Eflexis®, the latest advancement in scalable blood typing solutions

Grifols, a leading producer of plasma- derived medicines and recognized leader in transfusion medicine, has received U.S. Food and Drug...


23 Dec, 2018, 14:38 GMT Camurus AB: US FDA Issues A Tentative Approval of Brixadi™ (buprenorphine) Extended-release Injection for Treatment of Opioid Use Disorder

Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) has issued Camurus' US partner Braeburn a tentative...


21 Dec, 2018, 13:54 GMT Oxford BioTherapeutics Receives US FDA IND Clearance for OBT076

An experimental first in class ADC medicine for high risk Her2 negative breast cancer, gastric, lung, bladder and ovarian cancer patients - US phase...


21 Dec, 2018, 01:00 GMT Alma Receives Notice of Completion of Inquiry from FDA for FemiLift™ Pixel CO2 System

Alma Lasers, GmbH, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a ...


19 Dec, 2018, 13:07 GMT Hycor Biomedical Receives FDA 510(k) Clearance for NOVEOS™, Its Modern Allergy Testing Instrument

Hycor Biomedical, a leading manufacturer of in vitro diagnostic products for allergy and autoimmune testing, announced today that it has received U.S....


10 Dec, 2018, 12:00 GMT Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift™ Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


10 Dec, 2018, 03:30 GMT Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift™ Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


10 Dec, 2018, 03:30 GMT Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift™ Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


10 Dec, 2018, 01:00 GMT FDA Grants Orphan-drug Designation for TauRx's LMTX in Frontotemporal Dementia

TauRx, a leader in neurodegenerative disease research, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug...


04 Dec, 2018, 22:00 GMT Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift[TM] Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


21 Nov, 2018, 10:00 GMT OBI Pharma Granted FDA Orphan Drug Designation for OBI-888 for the Treatment of Pancreatic Cancer

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


13 Nov, 2018, 02:00 GMT Esco Medical secures CFDA approval on the MIRI(R) TL and MIRI(R) Embryo Incubators

Esco Medical, the IVF medical technology business unit of the Esco Group, today announced that it has received the China Food and Drug Administration ...


07 Nov, 2018, 10:00 GMT HemoScreen™ Hematology Analyzer for Point of Care, Receives FDA 510(k) Clearance

PixCell Medical announced today that The HemoScreen™ Hematology Analyzer received FDA 510(k) clearance, enabling commercialization in the USA. The...


29 Oct, 2018, 12:00 GMT Jazz Pharmaceuticals Announces FDA Approval of Xyrem® (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug...


25 Oct, 2018, 18:00 BST Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced ...


23 Oct, 2018, 14:22 BST COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression

COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received...


22 Oct, 2018, 11:15 BST FDA Grants Breakthrough Device Status for MediBeacon's Transdermal GFR Measurement System

MediBeacon Inc., whose largest shareholder is Pansend Life Sciences of HC2 Holdings, Inc. (NYSE MKT: HCHC), announced today the U.S. Food and Drug...


15 Oct, 2018, 16:00 BST CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System

CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions, is delighted to announce FDA...


12 Oct, 2018, 15:05 BST FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing

Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative...


11 Oct, 2018, 16:22 BST Transseptal Solutions Announces FDA Clearance of Its Novel Transseptal Access System for Transseptal Puncture and Left Atrial Navigation

Transseptal Solutions Ltd., developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial...