The US Food and Drug Administration (FDA) has approved the Auvi-Q (epinephrine injection USP) 0.1mg auto-injector as a treatment for life-threatening allergic reactions in children and infants. The Kaléo product was granted Priority Review by the FDA and is expected to be available in...

The US Food and Drug Administration has granted approval to Sublocade (buprenorphine extended release) for the treatment of patients with moderate to severe opioid use disorder. Shaun Thaxter, chief executive officer of Indivior, described the approval as an “important step forward for...

Adults with type 1 or type 2 diabetes have a new treatment option available to them following the US Food and Drug Administration’s (FDA) decision to approve Novo Nordisk's rapid-acting mealtime insulin Fiasp (insulin aspart).  The drug is indicated to improve glycemic control in adults...

The US Food and Drug Administration (FDA) has extended the approval of Pfizer’s drug Sutent (sunitinib malate) as an adjuvant treatment for adults at a high risk of experiencing a return of renal cell carcinoma following the removal of a kidney.  Adjuvant therapies are treatments...

The US Food and Drug Administration (FDA) has approved the first once-daily, two-drug single pill treatment for certain patients with human immunodeficiency virus type 1 (HIV-1). Approval for Juluca (dolutegravir and rilpivirine) was granted to ViiV Healthcare, a global specialist in HIV owned by...

A new treatment option is available to certain patients with hemophilia A following the US Food and Drug Administration’s (FDA) approval of Genentech’s drug Hemlibra (emicizumab-kxwh). The medication is approved for treatment of patients with hemophilia A who have developed Factor VIII...

The US Food and Drug Administration (FDA) Advisory Committee has voted 16-0 to approve semaglutide as a once-weekly treatment to improve glycemic control in adults with type 2 diabetes. Novo Nordisk submitted the application in December 2016 under the FDA’s Prescription drug user Fee Act...

The US Food and Drug Administration (FDA) has approved a new once-daily single inhaler triple therapy for treatment of certain adults with chronic obstructive pulmonary disease (COPD).  Trelegy Ellipta (furoate, umeclidinium, vilanterol) is indicated for patients on a fixed-dose combination...

The US Food and Drug Administration (FDA) has approved the first continuous glucose monitoring system for adult patients with diabetes. The FreeStyle Libre Flash Glucose Monitoring System enables patients to make decisions about their treatment without needing to calibrate using fingerstick...

Zelboraf (vemurafenib) has been approved for treatment of adult patients with a rare cancer of the blood. It is the first medication approved by the US Food and Drug Administration (FDA) for treatment of Erdheim-Chester Disease (ECD).  ECD is a rare blood cancer originating in the bone...

The US Food and Drug Administration (FDA) is looking into improved packaging, storage and disposal strategies to address the opioid abuse epidemic in the United States. In a statement released at the end of October, FDA Commissioner Scott Gottlieb, MD, reaffirmed the regulatory body's...

Patients in the United States who suffer from mantle cell lymphoma have a new treatment option available following the US Food and Drug Administration's (FDA's) decision to grant accelerated approval to Calquence (acalabrutinib). The AstraZeneca Pharmaceuticals drug was granted Priority Review,...

The US Food and Drug Administration (FDA) has announced its decision to recognize the capability of eight regulatory authorities in Europe, which it states will lead to greater efficiency in ensuring the safety of medicines and pharmacy products.  Inspections of manufacturing facilities by...

Scott Gottlieb, MD, US Food and Drug Administration (FDA) Commissioner, has outlined the FDA's plans to tackle the nation's opioid abuse epidemic. Speaking to the House Committee on Energy and Commerce Hearing, he described opioid addiction as the "biggest crisis facing public health...

The US Food and Drug Administration (FDA) has approved the indication of Stelara (ustekinumab) for adolescent patients with moderate to severe plaque psoriasis. Janssen Biotech, the manufacturer of the drug, described the approval as a "significant milestone" in the treatment of young people with...

The US Food and Drug Administration (FDA) has given the nod to Yescarta (axicabtagene ciloleucel), the first cell-based gene therapy granted approval for the treatment of certain types of non-Hodgkin lymphoma (NHL) and only the second gene therapy to gain FDA approval. The drug is indicated for...

The US Food and Drug Administration (FDA) has announced improvements to its Adverse Event Reporting System (FAERS). The system is a database of reported medication issues, including product quality complaints leading to adverse events, medication error reports and other adverse event...

Pfizer's Lyrica CR (pregabalin) extended-release tablets CV gained US Food and Drug Administration (FDA) approval for use treating neuropathic pain experienced by patients with diabetic peripheral neuropathy, and for managing postherpetic neuralgia.  The drug's safety and efficacy were...

The US Food and Drug Administration (FDA) has granted breakthrough therapy (BTD) designation to the AstraZeneca drug Tagrisso (osimertinib).  It is the sixth such designation granted to AstraZeneca oncology medicine since 2014. Tagrisso received BTD for first-line treatment of patients with...

A new treatment will soon be available for adults with relapsed follicular lymphoma, a slow-growing form of non-Hodgkin lymphoma, following the US Food and Drug Administration's (FDA) approval of Aliqopa (copanlisib). The drug was granted Accelerated Approval as it fills an unmet medical need....