Drug Pipeline News

The federal agency set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.

Read the latest medications for pediatric patients approved by the US Food and Drug Administration.

Linaclotide (LINZESS; Ironwood Pharmaceuticals) has been granted Priority Review by the US Food and Drug Administration for treating pediatric patients with functional constipation.

Aflibercept is now approved to treat 5 retinal conditions caused by ocular angiogenesis.

In a recent statement, the US Food and Drug Administration warned pharmacies and health care providers about unsafe aluminum levels for pediatric patients in Hospira’s unapproved potassium phosphates drug product.

A supplemental New Drug Application (sNDA) for abrocitinib (CIBINQO; Pfizer) in adolescents has been approved by the US Food and Drug Administration.

Lanadelumac (TAKHZYRO; Takeda) has received an approval for a supplemental Biologics License Application to prevent hereditary angioedema attacks in pediatric patients aged 2 years and older.

The US Food and Drug Administration has approved the use of a pre-filled tezepelumab (TEZSPIRE; Amgen and AstraZeneca) pen in patients aged 12 years and older with severe asthma.

Odactra (House Dust Mite Allergen Extract; ALK) has received approval from the US Food and Drug Administration for use in patients aged 12 to 17 years with house dust mite-induced allergic rhinitis.

After addressing a 2021 CRL, Verrica Pharmaceuticals vies for the agent to become the first drug approved to treat the common skin infection.

Orphagen Pharmaceuticals has announced their drug OR-499 received a rare pediatric disease designation for treating pediatric adrenocortical carcinoma from the US Food and Drug Administration.

A phase 3 trial of lomitapide showed safety and efficacy for treating homozygous familial hypercholesterolemia (HoFH) in pediatric patients aged 5 to 17 years.

The US Food Administration has agreed to review an application for nirsevimab (Beyfortus; AstraZeneca and Sanofi) to protect infants against RSV.

Novo Nordisk has announced their product Wegovy received approval from the US Food and Drug Administration for use in adolescents aged 12 years and older with obesity.

Arcutis Biotherapeutics, Inc has submitted a supplemental New Drug Application for roflumilast cream (ZORYVE) to the US Food and Drug Administration for treatment of plaque psoriasis in children aged 2 to 11 years.

If approved, according to AbbVie, linaclotide would be the first prescription therapy for FC in this patient population.

The FDA has approved atezolizumab for use in patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.

Boehringer Ingelheim and Eli Lilly have announced positive results from a phase 3 trial for Jardiance in reducing blood sugar levels in children with type 2 diabetes.

The US FDA announced the approval of teplizumab (Tzield), which is administered through IV infusion once daily for 14 consecutive days, for delaying the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Recently announced data from the INTEGUMENT-1 phase 3 clinical trial demonstrated positive safety and efficacy results for atopic dermatitis patients 6 years and older treated with roflumilast cream (Arcutis Biotherapeutics).

At ACR Convergence 2022, Amit Golding, MD, PhD, outlined drugs recently approved by the FDA, and discussed the requirements for biosimilars to meet approval.

At ACR Convergence 2022, Hyun Son, PharmD, discussed the role of the FDA’s Drug Shortage Staff in preventing and mitigating drug shortages.

Tina Q. Tan, MD, FAAP, FIDSA, FPIDS, sits down to discuss the rising threat of a "triple epidemic" consisting of influenza, COVID-19, and RSV in children.

Elia Pestana Knight, MD; and Whitney Mitchell discuss how CDKL5 deficiency disorder affects children, and how ganaxolone (ZTALMY; Marinus) can drastically improve and even save lives.

Pfizer announced positive data from a phase 3 trial on a bivalent RSV vaccine.

The FDA recently approved a drug treatment for HBV infection for pediatric patients 12 and older with compensated liver disease.

An advisory panel for the US Food and Drug Administration voted 14-1 to withdraw 17α-hydroxyprogesterone caproate (Makena; Covis Pharma) from the market.

Dr. Hyams, MD, discusses functional constipation in children and how positive results from a phase 3 trial on linaclotide will change treatment.

Moderna has announced that their latest BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, has been granted Emergency Use Authorization by the US Food and Drug Administration.

Eagle Pharmaceuticals and Enalare Therapeutics have announced that their ENA-001 drug for the treatment of Apnea of Prematurity has been granted an Orphan Drug Designation by the US Food and Drug Administration.