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 23, 2017, 06:59 ET PleurX™ Catheter System Receives FDA 510(k) Clearance for Specific Non-Malignant Recurrent Pleural Effusions

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced its PleurX™ catheter system received...


Jan 20, 2017, 11:15 ET OssDsign Announces FDA 510(k) Clearance of OSSDSIGN® Cranial for Sale in the USA

OssDsign AB, a Swedish designer, manufacturer and distributor of next generation implants for cranial and facial reconstruction, today announced...


Jan 20, 2017, 09:00 ET Bone Index Receives FDA 510(k) Clearance for the Second Generation Bindex® Point-of-Care Device to Help Physicians in Diagnosing Osteoporosis

Bone Index Ltd., one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration...


Jan 19, 2017, 16:05 ET FDA approves Trulance for Chronic Idiopathic Constipation

The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult...


Jan 19, 2017, 12:15 ET Breakthrough development for Americans with suspected heart attack - Next generation Troponin T test from Roche cleared by FDA

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood...


Jan 19, 2017, 07:59 ET Allergan Announces FDA Approval Of RHOFADE™ (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults

Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, announced today the approval of RHOFADE™ cream by the U.S. Food and Drug...


Jan 19, 2017, 07:05 ET IMBRUVICA® (ibrutinib) Approved by FDA for Marginal Zone Lymphoma (MZL) Patients Who Require Systemic Therapy and Have Received At Least One Prior Anti-CD20-Based Therapy

The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL) who...


Jan 19, 2017, 07:00 ET U.S. FDA Acknowledges Receipt of Shire's New Drug Application for SHP465 for ADHD

Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission...


Jan 19, 2017, 07:00 ET U.S. FDA Approves IMBRUVICA® (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma

AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved IMBRUVICA®...


Jan 18, 2017, 14:53 ET Leading Probiotic, GanedenBC30, Receives FDA GRAS for Infants

Ganeden continues its trend of being the first to receive regulatory approvals with the announcement that GanedenBC30® (Bacillus coagulans GBI-30,...


Jan 18, 2017, 08:00 ET FDA Grants Fast Track Designation for aTyr's Resolaris™ to Treat Limb Girdle Muscular Dystrophy 2B and Removes Partial Clinical Hold for Resolaris

aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address...


Jan 18, 2017, 05:00 ET Novel Anti-IL-6 Antibody for Rheumatoid Arthritis from WuXi-MedImmune Joint Venture Receives Clinical Trial Permit (CTP) from CFDA

Milestone represents first-time approval of biologics CTP for a joint multinational-local company venture in China WuXi AppTec, a global R&D...


Jan 18, 2017, 04:30 ET FDA Approves Obalon Balloon System

The OBALON 3-Balloon System is the first and only ingestible, non-surgical, fully reversible, 6 month, FDA-approved balloon system and Ultimate...


Jan 17, 2017, 09:45 ET Pulmatrix Drug Candidate Receives "Qualified Infectious Disease Product" (QIDP) Designation from the FDA

Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary...


Jan 17, 2017, 09:00 ET CyMedica Orthopedics® announces FDA clearance for e-vive™, the first app-driven muscle activation therapy and patient engagement solution for pre and post-operative knee surgery rehabilitation

CyMedica Orthopedics®, developer and manufacturer of innovative muscle rehabilitation systems announced that it received U.S. Food and Drug...


Jan 17, 2017, 07:15 ET OWC Pharmaceutical Research Corp Issues Annual Letter to Shareholders

OWC Pharmaceutical Research Corp. (OTCQB: OWCP), ("OWCP" or the "Company"), through its Israeli based fully owned subsidiary (One world Cannabis...


Jan 17, 2017, 07:00 ET BioLineRx Announces Initiation of Immuno-Oncology Phase 2 Study to Investigate Combination of BL-8040 and KEYTRUDA® for Pancreatic Cancer

BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing...


Jan 17, 2017, 07:00 ET Check-Cap Enrolls First Patient in Clinical Trial to Support CE Mark of Its C-Scan® Colorectal Cancer Screening System

Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK, CHEKW), a clinical stage medical diagnostics company developing a capsule-based...


Jan 13, 2017, 20:15 ET Delaware Surgeon Performs Innovative Non-Surgical Weight Loss Procedure

Dr. Isaias Irgau, from Christiana Institute of Advanced Surgery, is the first medical doctor to perform the newly FDA Approved Non-Surgical Weight...


Jan 13, 2017, 16:51 ET U.S. FDA Extends Review Period for Baricitinib, an Investigational Rheumatoid Arthritis Treatment

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has...