Krystle Vermes

Dalfampridine extended-release tablets deemed bioequivalent of Amprya.

Dalfampridine extended-release tablets is the bioequivalent of Amprya.

The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10 mg).

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.

The FDA has approved Imbruvica (ibrutinib) for the treatment of marginal zone lymphoma.

EZR-201 combines an angiotensin receptor blocker, valsartan, with Rubireten delivery technology for the treatment of hypertension and heart failure.

The FDA has finalized guidance designed to help investigational drug sponsors determine whether a new product can be potentially abused.

The FDA has announced 2 new draft guidances for medical product communications, such as off-label information and communicating cost-effective data

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.

Trial to assess efficacy of NRX-101 to maintain remission in patients with ASIB and depression.

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.

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).

MYL-14010 is designed to treat certain types of human epidermal growth factor receptor 2 (HER2) positive breast cancers.

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.

Mylan launches generic version of Pfizer’s Cerebyx, an injectable variety of fosphenytoin sodium.

Mylan has launched a generic version of Pfizer’s Cerebyx, an injectable variety of fosphenytoin sodium.

The ivWatch Model 400 for pediatric patients is now available in the United States.

The FDA has granted priority review for the supplemental new drug application (sNDA) from Bayer for Stivarga, also known as regorafenib.

The FDA has approved 3 abbreviated new drug applications (ANDAs) from Teligent.

The rule builds on the FDA’s ongoing effort to encourage complete postmarketing safety data on various biologic and device products.

Both combination product applicants and constituent part applicants are required to comply with postmarketing safety reporting rules.

FDA proposal would add 6 bulk drug substances and remove 4 substances that can be used in compounding.

Revisions would add 6 bulk drug substances and remove 4 substances that can be used in compounding.

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.

The FDA has issued a final rule on postmarketing safety reporting requirements as they pertain to combination products.

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.

An experimental DNA vaccine in the works may help treat peanut allergies.

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.

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 are expanding their collaboration to develop an Alzheimer’s drug known as MEDI1814, an antibody selective for amyloid-beta 42.