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

21 Jan, 2020, 10:00 GMT OBI Pharma Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

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


14 Jan, 2020, 07:00 GMT Phagenesis Receives FDA Breakthrough Device Designation for Its Phagenyx® System to Accelerate Removal of the Breathing Tube by Treating Neurogenic Dysphagia

Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device...


09 Jan, 2020, 12:30 GMT CPDC's Radiopharmaceutical Manufacturing Facility Receives Clearance from FDA

HAMILTON, Ontario, Jan. 9, 2020 /CNW/ - The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production ...


26 Dec, 2019, 10:00 GMT OBI Pharma Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

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


09 Dec, 2019, 17:13 GMT TechMah Medical & LimaCorporate Receive First 510k Approval for Smart SPACE Digital Technology

LimaCorporate is pleased to announce the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart SPACE is an innovative digital...


05 Dec, 2019, 11:00 GMT MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management

New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement TORONTO, Dec. 5, 2019 /CNW/ - MolecuLight...


04 Dec, 2019, 11:22 GMT FDA Grants Orphan Drug Designation to APR Applied Pharma Research's Investigational Drug for the Treatment of Epidermolysis Bullosa

APR Applied Pharma Research sa ("APR"), the Swiss pharma company focused in niche and rare therapeutic areas, announces that the US Food and Drug...


21 Nov, 2019, 20:32 GMT IRRAS Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®

IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has...


18 Nov, 2019, 21:59 GMT Accord and ADIENNE Enter into Exclusive Distribution Agreement for TEPADINA®

Accord Healthcare Limited ("Accord") and ADIENNE Pharma & Biotech S.A. ("ADIENNE") have entered into an exclusive licencing and distribution...


14 Nov, 2019, 08:00 GMT Ultromics Receives FDA Clearance for its AI-powered Decision Support System, EchoGo Core

Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography, has received 510(K)...


12 Nov, 2019, 13:05 GMT Pharmascience's generic Paliperidone Palmitate Prolonged-Release Injectable Suspension received for review by the FDA

MONTREAL, Nov. 12, 2019 /CNW Telbec/ - Pharmascience Inc. is proud to announce that the US Food and Drug Administration (FDA) communicated on October ...


12 Nov, 2019, 12:00 GMT Alkermes Announces Receipt of $150 Million Milestone Payment from Biogen Related to FDA Approval of VUMERITY™

Alkermes plc (Nasdaq: ALKS) today announced the receipt of a $150 million milestone payment from Biogen triggered by the recent U.S. Food and Drug...


08 Nov, 2019, 03:31 GMT Camurus Announces That FDA Grants Braeburn's Citizen Petition, Eliminating the Risk of Further Blocking of Brixadi™ From the US market

Camurus AB (NASDAQ STO: CAMX) today announces that the U.S. Food and Drug Administration (FDA) has granted Camurus' US partner Braeburn's request...


30 Oct, 2019, 11:30 GMT Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis

Biogen Inc. (Nasdaq: BIIB) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) approved VUMERITY™...


22 Oct, 2019, 13:40 BST BerGenBio Receives FDA Approval of Fast Track Designation for Bemcentinib

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer...


20 Sep, 2019, 15:03 BST Hovione Announces Successful End-of-phase 2 Meeting With the FDA and Outlines Phase 3 Program for Minocycline Topical Gel

Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of...


16 Sep, 2019, 14:00 BST SofWave Medical's Low-Divergence Ultrasound Technology Has Received FDA Clearance for the Aesthetic Treatment of Facial Lines and Wrinkles

Sofwave Medical Ltd., an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug...


16 Sep, 2019, 13:00 BST Glenmark Receives Orphan Drug Designation for GBR 1342, a Bispecific Antibody Candidate Under Evaluation for the Treatment of Multiple Myeloma

Glenmark Pharmaceuticals (Glenmark), a research-led, integrated global pharmaceutical company, today announced that the U.S. Food and Drug...


12 Sep, 2019, 18:53 BST LaunchPad Medical Received FDA Approval to Initiate a Clinical Study

LaunchPad Medical, Inc. has received approval from the U.S. Food and Drug Administration to initiate a two-site, 20-patient pilot clinical study to...


12 Sep, 2019, 15:42 BST V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension

V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and...


04 Sep, 2019, 14:39 BST Cantargia Submits Request for pre-IND Meeting on CAN04 With US FDA

Cantargia AB today announced that a request for a pre-IND meeting with the US FDA has been submitted. The purpose of the meeting is to discuss the...


04 Sep, 2019, 12:30 BST Endo Announces Approval of First Generic Orfadin® in U.S.

Endo International plc (NASDAQ: ENDP) today announced that Novitium Pharma, LLC, a partner of Endo's subsidiary Endo Ventures Limited, received...


03 Sep, 2019, 06:28 BST Positive Feedback From FDA Significantly Benefits Ongoing NefIgArd Pivotal Phase 3 Study

Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it has obtained written feedback from the US Food and Drug Administration (FDA) ...


29 Aug, 2019, 21:49 BST Concept Medical Inc. Granted 'Breakthrough Device Designation' From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon

The FDA received Concept Medical Inc. (CMI) request to designate MagicTouch AVF as a Breakthrough Device in July 2019. The proposed indications for...


14 Aug, 2019, 14:52 BST Pollogen's Leading Home-Use Device, TriPollar Stop, Receives FDA Clearance

FDA has cleared Pollogen's RF home-use device – TriPollar Stop – for sale in the US. TriPollar Stop, the innovative home-use device developed by...