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

Jan 06, 2017, 14:45 ET Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Bendamustine HCl Powder for IV (Treanda®)

Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA bendamustine hydrochloride powder for IV (infusion), 25...


Jan 06, 2017, 08:00 ET RG7916 Granted Orphan Drug Designation in the U.S. for the Treatment of Spinal Muscular Atrophy

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to...


Jan 05, 2017, 11:00 ET ivWatch Receives FDA 510 (K) Clearance to Significantly Advance the Safety of IV Therapy for Pediatric Patients

Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400 for pediatric patients under the age...


Jan 05, 2017, 09:30 ET Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer

Keystone Nano, Inc., a biopharmaceutical company focused on improving cancer treatments through the application of nanotechnology, announced today...


Jan 05, 2017, 08:30 ET XTL Biopharmaceuticals' Preclinical Studies of hCDR1 Demonstrate Therapeutic Potental In the Treatment of Sjögren's Syndrome

XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing...


Jan 05, 2017, 08:00 ET Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For SB-525 Gene Therapy Program For Hemophilia A

Sangamo BioSciences, Inc. (NASDAQ: SGMO) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational...


Jan 05, 2017, 08:00 ET Neurelis Announces Finalization Of Series B Financing

Neurelis, Inc. today announced that it has finalized a Series B financing round led by HBM Healthcare Investments. In addition, LYZZ Capital, which...


Jan 04, 2017, 16:05 ET Vermillion and ASPiRA LABS Announce Receipt of Formal FDA Clarification Regarding Ovarian Cancer Screening Alert

Vermillion (NASDAQ: VRML) and ASPiRA LABS, a Vermillion company, today announced the receipt of an FDA Clarification Letter regarding OVA1 (MIA)...


Jan 04, 2017, 10:07 ET NeuroRx announces FDA IND clearance for NRX-101 phase 2b/3 study and publication of promising biomarker data

Biotech Showcase at the JP Morgan Healthcare Conference NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute...


Jan 04, 2017, 09:39 ET Roche launches cobas® c 513 analyzer and HbA1c Gen. 3 assay to meet increasing demand for testing of people with diabetes

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and...


Jan 04, 2017, 09:00 ET Senhwa Biosciences CX-4945 Granted Orphan Drug Designation by the US FDA in Cholangiocarcinoma

Senhwa Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CX-4945 for the...


Jan 04, 2017, 09:00 ET CytRx Granted Type B Pre-NDA Meeting with U.S. FDA for Registration Pathway with Aldoxorubicin as a Treatment for Patients with Relapsed Soft Tissue Sarcomas

CytRx Corporation (NASDAQ: CYTR), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing new...


Jan 04, 2017, 08:45 ET Registrar Corp FSMA Wizard Now Includes FDA's Intentional Adulteration Rule

Registrar Corp's FSMA Compliance Wizard, a free tool that helps food facilities, importers, and farms determine their possible requirements under...


Jan 04, 2017, 07:35 ET FDA Accepts For Filing Supplemental New Drug Application (sNDA) For LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg

Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a nonprofit global women's health pharmaceutical company,...


Jan 04, 2017, 06:30 ET FDA aprova indicação de Jardiance (empagliflozina) para reduzir risco de morte por causa cardiovascular, em pacientes com diabetes tipo 2 e doença cardiovascular

A ameaça iminente de infarto e AVC é uma das maiores preocupações de quem convive com o diabetes, afinal, cerca de metade desses pacientes morre em...


Jan 03, 2017, 08:20 ET Glenmark Pharmaceuticals Receives FDA Clearance of IND for GBR 1302-BEAT™ Phase I Trial

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's...


Jan 03, 2017, 08:00 ET Teligent, Inc. Announces FDA Approval For Three Abbreviated New Drug Applications

Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of three of...


Jan 03, 2017, 08:00 ET FDA Grants PMA Approval for Hologic's Aptima® HIV-1 Quant Assay

Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted PMA approval for the Company's HIV-1...


Jan 03, 2017, 07:35 ET Allergan Announces FDA Approval of NATRELLE INSPIRA® SoftTouch Breast Implants

Allergan plc (NYSE: AGN) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA®...


Jan 02, 2017, 03:00 ET BiondVax Receives $US 2.8 Million Investment From Angels High Tech Investments Ltd.

Investor Shares BiondVax Vision of Commercializing World's First Universal Flu Vaccine BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV)...


Dec 29, 2016, 16:23 ET Mylan Launches Generic Concerta® Tablets

Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg...


Dec 29, 2016, 07:00 ET Mylan Launches Generic Cerebyx® Injection

Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Fosphenytoin Sodium Injection USP, 75 mg/mL, (50 mg PE*/mL), packaged in 100 mg...


Dec 28, 2016, 16:33 ET Mylan Launches Generic Zovia® Tablets

Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg / 0.05 mg. Mylan's...


Dec 28, 2016, 05:00 ET Escend Pharmaceuticals, Inc., Receives Second Orphan Drug Designation from FDA for ES-3000

Escend Pharmaceuticals, Inc., a privately held company focused on the development of small molecule therapeutics for oncology orphan diseases,...