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

Jun 25, 2019, 08:00 ET Non-GMO BESTEVIA® Reb E receives FDA No Objection Letter

SweeGen, Inc., a stevia-based sweetener company, announced that the U.S. Food and Drug Administration (FDA) issued a GRAS (Generally Recognized As...


Jun 24, 2019, 07:00 ET Correvio Resubmits Brinavess (Vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation

NASDAQ: CORV TSX: CORV VANCOUVER, June 24, 2019 /CNW/ - Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused...


Jun 20, 2019, 07:30 ET Edesa Biotech Receives Approval to Proceed with U.S. Clinical Study

Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, reported today that the U.S. Food and Drug Administration has...


May 22, 2019, 08:00 ET EpiBone, Inc. Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF

EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed...


May 01, 2019, 07:00 ET Bausch + Lomb Canada Supports Moments that Matter with the 'Why Eye Care' Campaign for Vision Health Month

One share = $1 investment to Fighting Blindness Canada TORONTO, May 1, 2019 /CNW Telbec/ - This May, for Vision Health Month, Bausch + Lomb Canada is ...


Apr 25, 2019, 13:17 ET FDA Approves Bausch Health's DUOBRII™ (Halobetasol Propionate And Tazarotene) Lotion 0.01%/0.045% 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...


Apr 22, 2019, 15:30 ET Lilly Announces Positive Top-Line Results for COAST-X, a 52-Week Placebo-Controlled Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis

TORONTO, April 22, 2019 /CNW/ - Eli Lilly and Company announced today that Taltz® (ixekizumab) met the primary and all major secondary endpoints in...


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....