Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

ENLIGHTENVUE: enlightenVue's Single Use Micro-Endoscope complies with new FDA recommendations to increase patient safety

The innovative micro-endoscope with multiple working channels is single use, eliminating the risk of transmitting infections among patients.

DURECT: Announces FDA Advisory Committee Meeting to Review POSIMIR® for the Treatment of Post-Surgical Pain

DURECT Corporation (Nasdaq: DRRX) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).

IPSEN: Announces FDA Approval of Dysport® (abobotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Children, Excluding Cerebral Palsy

Dysport is the first and only FDA-approved botulinum toxin for treatment of both pediatric upper and lower limb spasticity

NOVO NORDISK: FDA approves Rybelsus® (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes

Rybelsus® represents an innovation in diabetes treatment by providing a GLP-1 receptor agonist in an oral formulation

U.S. FDA: FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.

ENDO: Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite

Endo International plc (NASDAQ: ENDP) announced today that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.

ICUS: Simple CEUS Scan Helps Diagnose Liver Cancer When MRI is Uncertain

A new study shows that a simple, non-invasive “contrast enhanced ultrasound” (CEUS) scan can be more accurate and reliable than a more expensive MRI procedure for diagnosis of liver tumors and determining whether they are cancerous.

ASTEX PHARMACEUTICALS: Announces That Its Novel, Oral Hypomethylating Agent ASTX727 Has Been Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes (Including Chronic Myelomonocytic Leukemia) by the US FDA

Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

U.S. FDA: Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications

Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves.

APIFIX: Receives FDA Approval to Commercialize MID-C System for Motion-Preserving Deformity Treatment of Progressive Idiopathic Scoliosis in Adolescents

FDA approves ApiFix’s unique self-adjusting pediatric device designed to benefit young scoliosis patients with a less invasive surgical treatment

U.S. FDA: Requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks

The U.S. Food and Drug Administration is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy, in Melbourne, Florida.

STALICLA: Announces Completion of pre-IND Meeting With FDA on STP1 for Subgroup of Patients With Autism Spectrum Disorder (ASD)

STP1 is a pioneering investigational precision medicine that aims to provide an effective treatment option for a subgroup of patients with ASD (referred to as ‘Phenotype 1’). Phenotype 1 is estimated to include 20% of the total ASD population (2 million out of 10 million patients with ASD across Europe and North America), meaning STP1 has the potential to be a ‘game-changing’ influence in the field.

FDA Reporter