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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09 Apr, 2019, 14:00 BST Innoblative's SIRA™ RFA Electrosurgical Device Receives FDA Clearance

Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical...


08 Apr, 2019, 12:30 BST GT Biopharma Receives Institutional Review Board Approval to Proceed With in Human FDA Phase 1 Clinical Trial

T Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology biotechnology company focused on innovative treatments based on the Company's...


28 Mar, 2019, 13:30 GMT Mundipharma EDO GmbH: US FDA Grants Orphan Drug Designation for Tinostamustine in Very Rare Blood Cancer

Mundipharma EDO GmbH, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today announced that the US FDA has granted...


21 Mar, 2019, 13:00 GMT GenePOC Obtains FDA Clearance for Its GenePOC™ Strep A Test in the US

GenePOC Inc., member of the Debiopharm Group, announces its third test to be cleared by the FDA, the GenePOC Strep A assay, to be used with the...


20 Mar, 2019, 23:25 GMT Jazz Pharmaceuticals Announces U.S. FDA Approval of Sunosi™ (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Sunosi™ (solriamfetol) to improve...


19 Mar, 2019, 13:30 GMT Why the FDA Commissioner Pushed to Shorten Medical Device Approval Process

We all know the FDA is the arm of the U.S. government that, among other things, controls and oversees the approval process for medical device...


12 Mar, 2019, 20:20 GMT Hematogenix Launches FDA Approved Companion Diagnostic Immuno-oncology Test for Triple-Negative Breast Cancer

Hematogenix®- a global leader in the field of integrated pathology services for drug development and immuno-oncology testing, today announced the...


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...