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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Apr 11, 2019, 14:43 ET Health Canada issues Notice of Compliance with Conditions (NOC/c) for LibtayoTM (cemiplimab), the first and only biologic for the treatment of advanced cutaneous squamous cell carcinoma (CSCC)

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) * CSCC is the second most common skin cancer in Canadai TORONTO, April 11, 2019 /CNW Telbec/ - Sanofi...


Apr 08, 2019, 07:30 ET 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...


Feb 25, 2019, 07:00 ET Bausch + Lomb Announces FDA Approval Of LOTEMAX® SM (loteprednol Etabonate Ophthalmic Gel) 0.38% For The Treatment Of Postoperative Inflammation And Pain Following Ocular Surgery

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


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...