FDA

June 13, 2016June 13, 2016

FDA Approves First Blood Test to Detect Specific Mutations in Non-Small Cell Lung Cancer

Lung Cancer, News

The U.S Food and Drug Administration (FDA) has approved the first blood-based genetic test designed to detect mutations in the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) ... Read more

May 3, 2016May 4, 2016

FDA Approves COPD Treatment Bevespi Aerosphere, a Long-acting Dual Bronchodilator

Chronic Bronchitis, COPD, Emphysema, News

The U.S. FDA has approval AstraZeneca’s Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) for long-term maintenance treatment of airflow obstruction in patients suffering from chronic obstructive pulmonary disease (COPD), including emphysema and/or chronic bronchitis. ... Read more

May 2, 2016May 2, 2016

Cumberland Pharmaceuticals to Begin Development of Scleroderma Drug Vasculan

News, Scleroderma

Cumberland Pharmaceuticals recently added Vasculan to its clinical portfolio. The company has began the clinical development of Vasculan (ifetroban) oral capsule for the treatment of systemic sclerosis (SSc), also know ... Read more

April 18, 2016April 19, 2016

FDA Approves Corbus Phase 2 Trial Extension of Systemic Sclerosis Drug Resunab

News, Scleroderma

Corbus Pharmaceuticals, a clinical stage company targeting rare, chronic inflammatory and fibrotic diseases, recently received approval by the U.S. Food and Drug Administration (FDA) for a 12-month open-label extension trial ... Read more

April 15, 2016April 15, 2016

Antimicrobial Agent Targeting Resistant CF Infections Named ‘Orphan Drug’ by FDA

Cystic Fibrosis, News

TGV-Inhalonix, Inc., recently announced that its drug candidate, the antimicrobial agent Mul-1867, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of antibiotic-resistant bacterial ... Read more

March 28, 2016March 28, 2016

FDA Approves Teva’s Asthma Drug Cinqair as Add-on Treatment

Asthma, News

Teva Pharmaceutical Industries recently announced the approval of Cinqair (reslizumab) injection by the U.S. Food and Drug Administration (FDA) as an add-on maintenance treatment for patients with severe asthma, age 18 and ... Read more

March 4, 2016March 4, 2016

Genentech’s Application of Xolair for Allergic Asthma in Kids Is Under FDA Review

Asthma, News

Genentech recently announced that its supplemental Biologics License Application (sBLA) for extension of Xolair (omalizumab) in allergic asthma in pediatric patients has been accepted by the U.S. Food and Drug Administration (FDA). ... Read more

February 10, 2016February 18, 2016

Vertex CF Drug, Kalydeco, Rejected as Therapy for Specific Group of Mutations by FDA

Cystic Fibrosis, News

Vertex Pharmaceuticals recently received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) stating that its supplemental New Drug Application (sNDA) could not be approved in its current ... Read more

February 2, 2016February 3, 2016

FDA Approves IND Application for Multidrug-Resistant Bacterial Infections

Bronchiectasis, COPD, Cystic Fibrosis, Emphysema, News, Pneumonia

Matinas BioPharma Holdings recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, and the company can now begin a Phase 1 clinical trial to ... Read more

January 21, 2016January 25, 2016

Cystic Fibrosis Treatment Granted FDA Orphan Drug Status

Cystic Fibrosis, News

Boulder, Colorado-based Nivalis Therapeutics recently announced the U.S. Food and Drug Administration (FDA) has granted the company’s lead clinical candidate, N91115, Orphan Drug Designation for the treatment of cystic fibrosis (CF). The ... Read more