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

Jul 12, 2019, 13:19 ET Media Advisory - Minister Monsef to Make a Clean Technology Announcement

OTTAWA, July 12, 2019 /CNW/ - Minister of International Development and Minister for Women and Gender Equality, the Honourable Maryam Monsef, on...


Jul 12, 2019, 07:00 ET ESPEROCT® is now approved in Canada for the Treatment of Hemophilia A in both Children and Adults

New treatment can help Canadians living with hemophilia A better manage their bleeding episodes TORONTO, July 12, 2019 /CNW/ - Novo Nordisk announced ...


Jul 10, 2019, 07:00 ET Health Canada has authorized VYVANSE® (lisdexamfetamine dimesylate), the first and only, chewable tablet for the treatment of attention deficit/hyperactivity disorder (ADHD)1*

VYVANSE® offers an additional option for patients who prefer the convenience of a chewable tablet, or who have difficulty swallowing medication...


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/ -...