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Ocular Therapeutix resubmits NDA for DEXTENZA

Ocular Therapeutix™, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, has announced the resubmission of the Company's New Drug Application to the U.S. Food and Drug Administration for its lead product candidate DEXTENZA™ 0.4mg, for the treatment of ocular pain following ophthalmic surgery.

30 Jun 2018

PanOptica doses first patient in Phase 1/2 dose-ranging clinical trial of PAN-90806

PanOptica, Inc., a private biopharmaceutical company focused on developing innovative ophthalmology therapies, today announced that the Company has dosed the first patient in a Phase 1/2 dose-ranging clinical trial of PAN-90806, a once-daily topical eye drop formulation of a small-molecule anti-vascular endothelial growth factor (anti-VEGF) for the treatment of neovascular eye diseases.

22 May 2018

KARL STORZ launches new PDD Blue Cystoscopy system for enhanced detection of NMIBC tumors

KARL STORZ Endoscopy-America, Inc., announces the commercial launch of the PDD Blue Light Flexible Video Cystoscopy System for enhanced detection of non-muscle invasive bladder cancer.

18 May 2018

FDA clears Turnstone Biologics' IND for immunotherapy targeting HPV positive solid tumors

Turnstone Biologics today announced it has received U.S. Food and Drug Administration clearance of its Investigational New Drug Application for MG1-HPV for the treatment of patients with human papillomavirus positive solid tumors.

16 May 2018

Celgene announces regulatory information about investigational compound for relapsing multiple sclerosis

Celgene Corporation today announced that it has received a Refusal to File letter from the United States Food and Drug Administration regarding its New Drug Application for ozanimod in development for the treatment of patients with relapsing forms of multiple sclerosis.

27 Feb 2018

Novartis announces FDA approval of its first and only CML therapy with TFR data in product label

Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna® (nilotinib) US product label.

26 Dec 2017

First short-acting ‘follow-on’ insulin receives FDA approval to treat diabetes

The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

12 Dec 2017

Ozanimod effective against multiple sclerosis, enters New Drug Approval process with FDA

Celgene Corporation recently announced results from two phase 3 trials evaluating the efficacy and safety of the drug ozanimod.

10 Nov 2017

Sunovion announces results from Phase 3 clinical study of new drug in children, adolescents with bipolar depression

Sunovion Pharmaceuticals Inc. today announced post-hoc analysis results of a positive Phase 3 placebo-controlled clinical study, as well as interim data from a long-term open-label extension study evaluating Latuda (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression).

28 Oct 2017

U.S. FDA approves updated labeling for pan-genotypic single tablet regimen for HCV/HIV co-infected patients

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved updated labeling for Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

1 Aug 2017

FDA to expedite orphan drug processing queues

In a press release the U.S. Food and Drug Administration (FDA) released a plan for eliminating the backlog regarding orphan drug application status and also released plans for deadlines to clear the queues.

29 Jun 2017

FDA takes important steps to increase patient access to prescription drugs

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.

28 Jun 2017

LimTox online software tool provides information on drug hepatotoxicity

The Biological Text Mining Unit presents in a recent Nucleic Acids Research paper the LimTox online software tool developed at the Spanish National Cancer Research Centre.

1 Jun 2017

FDA issues Complete Response Letter for Sunovion’s New Drug Application to treat COPD patients

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

27 May 2017

Innovus Pharma announces launch of AllerVarx for relieving nasal, ocular symptoms in allergic patients

Innovus Pharmaceuticals, Inc., an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men's and women's health and respiratory diseases, today announced the launch of AllerVarx in the U.S.

24 May 2017

New spherical nucleic acid drug crosses blood-brain barrier to target brain tumors in animals

The first drug using spherical nucleic acids to be systemically given to humans has been developed by Northwestern University scientists and approved by the Food and Drug Administration as an investigational new drug for an early-stage clinical trial in the deadly brain cancer glioblastoma multiforme.

12 May 2017

UAB spinoff develops drug-resistant immunotherapy to combat solid tumors

The University of Alabama at Birmingham and two partner institutions have received a European patent for their novel approach to fighting cancer, an approach that is led by the UAB spinoff biopharmaceutical company Incysus Ltd.

5 May 2017

Researchers use novel phage therapy to treat patient infected with multidrug-resistant bacterium

Scientists and physicians at University of California San Diego School of Medicine, working with colleagues at the U.S. Navy Medical Research Center - Biological Defense Research Directorate, Texas A&M University, a San Diego-based biotech and elsewhere, have successfully used an experimental therapy involving bacteriophages -- viruses that target and consume specific strains of bacteria -- to treat a patient near death from a multidrug-resistant bacterium.

25 Apr 2017

Cannabidiol shows promise to reduce seizures for people with difficult-to-treat epilepsy

Taking cannabidiol may cut seizures in half for some children and adults with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy, according to new information released today from a large scale controlled clinical study that will be presented at the American Academy of Neurology's 69th Annual Meeting in Boston, April 22 to 28, 2017.

19 Apr 2017

OSU scientists find way to fight solid tumors using new cancer-drug delivery system

A new cancer-drug delivery system shows the ability to exploit the oxygen-poor areas of solid tumors that make the growths resistant to standard chemotherapy and radiation treatment.

4 Apr 2017