CLINICAL ROLE -
Amprya Bioequivalent Approved for Multiple Sclerosis
Dalfampridine extended-release tablets deemed bioequivalent of Amprya.
Bioequivalent Multiple Sclerosis Drug Approved by FDA
Dalfampridine extended-release tablets is the bioequivalent of Amprya.
FDA Approves Ampyra Bioequivalent for Multiple Sclerosis
The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10 mg).
Researchers Find New Way to Inhibit Sensory Neuron Growth
In a study published in the Journal of Clinical Investigation, the researchers demonstrated a way to promote sensory neuron growth by blocking a specific molecular signaling pathway.
FDA Approves Imbruvica for the Treatment of Marginal Zone Lymphoma in Some Patients
The FDA has approved Imbruvica (ibrutinib) for the treatment of marginal zone lymphoma.
NDA Filed for Novel Hypertension Drug
EZR-201 combines an angiotensin receptor blocker, valsartan, with Rubireten delivery technology for the treatment of hypertension and heart failure.
FDA Issues Guidance for Evaluating Abuse Potential of Drugs
The FDA has finalized guidance designed to help investigational drug sponsors determine whether a new product can be potentially abused.
FDA Drafts 2 Guidances on Medical Product Communications
The FDA has announced 2 new draft guidances for medical product communications, such as off-label information and communicating cost-effective data
FDA Accepts NDA for Investigational Hypertension Drug
The FDA has accepted the new drug application (NDA) for EZR-201, an investigational product from Ezra Innovations for the treatment of hypertension and heart failure.
FDA Advances Acute Suicidal Ideation and Behavior Treatment
Trial to assess efficacy of NRX-101 to maintain remission in patients with ASIB and depression.
FDA Approves Investigational New Drug Application for Ceramide NanoLiposome
The FDA has approved the investigational new drug application from Keystone Nano for Ceramide NanoLiposome to assess the product as a form of treatment for solid tumors.
NeuroRx to Proceed with Study for Investigational ASIB Drug
The FDA has given clearance to NeuroRx to proceed with a phase 2B/3 study protocol under an investigational new drug application for NRX-101, the first oral therapy for acute suicidal ideation and behavior (ASIB).
FDA Accepts BLA for Breast Cancer Biosimilar Treatment
MYL-14010 is designed to treat certain types of human epidermal growth factor receptor 2 (HER2) positive breast cancers.
Fast Track Designation for Refractory CMV After Transplant Treatment
The FDA has granted fast track designation to ViraCyte for Viralym-C, its T-cell immunotherapy product indicated to treat refractory cytomegalovirus after a patient has received a stem cell transplant.
Generic Seizure Medication Launched
Mylan launches generic version of Pfizer’s Cerebyx, an injectable variety of fosphenytoin sodium.
Mylan Launches Generic Version of Injectable Cerebyx
Mylan has launched a generic version of Pfizer’s Cerebyx, an injectable variety of fosphenytoin sodium.
FDA Clears Medical Device for IV Monitoring in Pediatric Patients
The ivWatch Model 400 for pediatric patients is now available in the United States.
FDA Grants Priority Review for Liver Cancer Treatment
The FDA has granted priority review for the supplemental new drug application (sNDA) from Bayer for Stivarga, also known as regorafenib.
Teligent Receives FDA Approval for 3 ANDAs
The FDA has approved 3 abbreviated new drug applications (ANDAs) from Teligent.
FDA Issues Final Rule for Combination Drug Postmarketing Safety Report
The rule builds on the FDAâ€™s ongoing effort to encourage complete postmarketing safety data on various biologic and device products.
Final Rule on Postmarketing Safety Reporting Issued by FDA
Both combination product applicants and constituent part applicants are required to comply with postmarketing safety reporting rules.
FDA Pushes for Removal, Addition of Substances to 503A Bulks List
FDA proposal would add 6 bulk drug substances and remove 4 substances that can be used in compounding.
FDA Seeks Revisions to Bulk Substances List for Drug Compounding
Revisions would add 6 bulk drug substances and remove 4 substances that can be used in compounding.
FDA Proposes the Removal and Addition of Substances to Its 503A Bulks List
The FDA has created a new proposed rule that adds 6 bulk drug substances to an existing list of substances that can be used in compounding. It has also proposed the removal of 4 other bulk drug substances from the list.
FDA Issues Final Rule for Postmarketing Safety Reporting
The FDA has issued a final rule on postmarketing safety reporting requirements as they pertain to combination products.
Mylan Launches Generic Concerta and Zovia in the US Market
Mylan launched 2 generic pharmaceutical products at the end of December for the treatment of attention deficit hyperactivity disorder (ADHD) and the prevention of pregnancy.
Peanut Allergy Vaccine Receives Fast Track Designation
An experimental DNA vaccine in the works may help treat peanut allergies.
FDA Extends Review of Ocrevus
The FDA has extended the Prescription Drug User Fee Act date for the Biologics License Application review of Roche’s Ocrevus (ocrelizumab) to March 28, 2017.
FDA Approves Label Expansion for Adynovate
The FDA has approved Adynovate from Shire, an extended circulating half-life recombinant Factor VIII treatment for hemophilia A in pediatric patients younger than age 12.
AstraZeneca and Eli Lilly Collaborate on Potential Alzheimer's Drug
AstraZeneca and Eli Lilly are expanding their collaboration to develop an Alzheimer’s drug known as MEDI1814, an antibody selective for amyloid-beta 42.
2 Clarke Drive Cranbury, NJ 08512