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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Feb 07, 2019, 08:00 ET 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 ...


Jan 30, 2019, 08:54 ET SpeakEasy announces it has successfully completed the committee review

/THIS NEWS RELEASE IS NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES FOR DISSEMINATION IN THE UNITED STATES/ VANCOUVER, Jan. 30, 2019 /CNW/ -...


Jan 15, 2019, 08:19 ET Beleave Receives Health Canada Authorization to Sell Cannabis Oils

TORONTO, Jan. 15, 2019 /CNW/ - Beleave Inc. (CSE: BE) (OTCQX: BLEVF) ("Beleave" or the "Company") is excited to announce its wholly-owned subsidiary...


Jan 08, 2019, 08:13 ET Embrace by Empatica Receives First of Its Kind FDA Clearance in Epilepsy for Children

BOSTON, Jan. 8, 2019 /CNW/ - Embrace by Empatica has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in children....


Dec 17, 2018, 10:00 ET Sundial's Rocky View Facility Receives Processing and Medical Sales Licenses

CALGARY, Dec. 17, 2018 /CNW/ - Sundial Growers Inc. ("Sundial") today announced that its Rocky View facility received its standard processing and...


Dec 17, 2018, 08:04 ET Health Canada Approves DARZALEX® (daratumumab) for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible

DARZALEX® combination therapy significantly reduced the risk of disease progression or death compared to a preferred regimen alone.1,2 TORONTO, Dec....


Dec 17, 2018, 07:30 ET U.S. FDA Approves Removal of "Not for Home Use" Label Restriction for Pliaglis®

LAVAL, QC, Dec. 17, 2018 /CNW/ - Crescita Therapeutics Inc. (TSX: CTX) (Crescita or the Company), a Canadian commercial dermatology company with a...


Dec 17, 2018, 07:00 ET Cipher Pharmaceuticals Announces PLECANATIDE Accepted for Review by Health Canada

MISSISSAUGA, ON, Dec. 17, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced that its New Drug Submission ("NDS") for plecanatide for ...


Dec 05, 2018, 09:34 ET Prometic to Initiate PBI-4050 Pivotal Phase 3 Clinical Trial in Alström Syndrome

Clinical-regulatory pathway defined following recent meetings with regulatory authorities Pivotal Phase 3 clinical trial design finalized to support...


Dec 05, 2018, 08:00 ET Bausch + Lomb Receives 510(K) Clearance From FDA For Bausch + Lomb Ultra® Multifocal For Astigmatism Contact Lenses

Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced that...


Nov 26, 2018, 07:00 ET Health Canada Has Now Authorized ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] in Pediatrics for Treatment of Children Under 12 with Hemophilia A[1]

Canadian children now have access to ADYNOVATE®, which offers a twice-weekly prophylaxis dosing schedule and on-demand control of bleeding episodes1...


Nov 22, 2018, 13:32 ET Medtronic Receives Health Canada Licence for Visualase™ MRI-Guided Laser Ablation System

Minimally Invasive Application Allows for Improved Precision and Faster Recovery Time BRAMPTON, ON, Nov. 22, 2018 /CNW/ - Medtronic of Canada Ltd., a ...


Nov 15, 2018, 14:56 ET American Journal of Infection Control publishes TSO3 study on terminal sterilization of duodenoscopes

QUÉBEC CITY, QC and MYRTLE BEACH, SC, Nov. 15, 2018 /CNW Telbec/ - TSO3 Inc. ("TSO3" or the "Company") (TSX: TOS), an innovator in sterilization...


Nov 12, 2018, 21:00 ET 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 ...


Nov 07, 2018, 07:00 ET Bausch Health Announces U.S. Launch Of BRYHALI™ (halobetasol propionate) Lotion, 0.01%, For Plaque Psoriasis In Adults

Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health...


Oct 24, 2018, 09:56 ET Bayer Inc. receives approval for hemophilia A treatment Jivi®

Extended half-life product that offers a reduction in dosing frequency and improved bleeding protection May be adjusted to every five days and...


Oct 17, 2018, 16:05 ET Natura Receives Health Canada Approval for Third and Fourth Flowering Rooms in Leamington Facility

TORONTO, Oct. 17, 2018 /CNW/ - Natura Naturals Inc. ("Natura") has received Health Canada approval to add "Grow Space 3" and "Grow Space 4" to their...


Oct 17, 2018, 08:26 ET Ascensia Diabetes Care Receives Amended Health Canada License for Contour® Next Link 2.4 for Use With the Minimed™ 670g Insulin Pump System

MISSISSAUGA, ON, Oct. 17, 2018 /CNW/ - Ascensia Diabetes Care today announced the receipt of an amended license from Health Canada for the CONTOUR®...


Oct 16, 2018, 08:15 ET The Green Organic Dutchman receives medical sales license from Health Canada

TORONTO, Oct. 16, 2018 /CNW/ - The Green Organic Dutchman Holdings Ltd. (the "Company" or "TGOD") (TSX:TGOD) (US:TGODF) is pleased to announce it has ...


Oct 15, 2018, 11:00 ET 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...


Oct 11, 2018, 08:00 ET Bausch Health Announces Publication Of Pivotal Phase 3 Efficacy And Safety Data On ALTRENO™ (tretinoin) Lotion, 0.05% In The Journal Of Drugs In Dermatology

Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health...


Sep 18, 2018, 07:00 ET New indication will help Canadians with coronary artery disease prevent heart attack, stroke or death

Rivaroxaban (XARELTO®) 2.5 mg twice daily in combination with acetylsalicylic acid (ASA) 75 mg -100 mg once daily offers a new way to treat Canadians ...


Sep 07, 2018, 09:42 ET GTEC Holdings Receives Health Canada Approval to Expand Scope of Dealer's License to Include Extraction of Cannabis Oil

/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION, DISTRIBUTION OR DISSEMINATION DIRECTLY, OR INDIRECTLY, IN WHOLE ...


Aug 24, 2018, 10:25 ET Ortho Dermatologics Receives FDA Approval For ALTRENO™ (tretinoin 0.05%) Lotion For Acne

Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc....


Aug 22, 2018, 15:30 ET Clarion Medical Technologies Inc. to Distribute Health Canada Approved DWP-450(prabotulinumtoxinA) in Canada

CAMBRIDGE, ON, Aug. 22, 2018 /CNW/ - Clarion Medical Technologies, a leading Canadian provider of medical and aesthetic equipment and consumables, is ...