Olaparib Granted Priority Review for HRR-Mutated Metastatic Castration-Resistant Prostate Cancer
FDA approval decision expected in the second quarter of 2020.
Sunosi for Excessive Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea
Solriamfetol (Sunosi, Jazz Pharmaceuticals) to treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea was approved on March 20, 2019.
FDA OKs Cardiovascular Risk Reduction Indication for Semaglutide
The FDA has approved semaglutide (Ozempic, Novo Nordisk) for the reduction of major adverse cardiovascular (CV) events in patients with type 2 diabetes and established CV disease.
FDA Grants Fast Track Designation to Flu Vaccine for Older Adults
Novavax’s recombinant quadrivalent flu vaccine candidate (NanoFlu) is being evaluated in an ongoing phase 3 clinical study for use in older adults.
Most Valuable Drugs in the 2020 Pipeline
Here are the top drugs expected to be approved this year.
Investigational Immunotherapy for Peanut Allergy Shows Long-Term Clinical Benefit
Viaskin Peanut (DBV Technologies) achieved durable, long-term clinical benefit in peanut-allergic children.
Dapagliflozin Granted Priority Review for Heart Failure with Reduced Ejection Fraction
AstraZeneca’s supplemental New Drug Application for dapagliflozin (Farxiga) has been granted Priority Review by the FDA.
FDA OKs Fast-Acting Insulin Aspart Injection for Children with Diabetes
Insulin aspart injection (Fiasp, Novo Nordisk) has been approved for use as a new mealtime insulin option for children with diabetes.
FDA Issues Complete Response Letter to Investigational Long-Acting HIV Regimen
The New Drug Application is seeking approval for ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV in adults.
FDA Approves Maintenance Olaparib for Metastatic Pancreatic Cancer
Olaparib (Lynparza, Merck and AstraZeneca) is approved for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic cancer.
FDA Approves Generic Versions of Apixaban
The approvals were granted to generic apixaban applications from Micro Labs Limited and Mylan Pharmaceuticals Inc.
Top FDA Drug Approvals from 2019
Our most-read FDA approval articles from 2019.
FDA Approves Novel Acute Migraine Treatment
Ubrogepant (Ubrelvy) is the first oral calcitonin gene-related peptide receptor antagonist approved by the FDA for the acute treatment of migraine.
FDA OKs New Treatment Option for Previously-Treated HER2-Positive Breast Cancer
Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo and AstraZeneca) is a new treatment option for patients with HER2-positive breast cancer who have progressed after 2 or more prior regimens.
Grifols Launches Xembify, A New Primary Immunodeficiency Treatment
20% subcutaneous immunoglobulin therapy.
FDA OKs Expanded Indication for Vascepa in Cardiovascular Risk Reduction
Officials with the FDA have approved a new indication and label expansion for icosapent ethyl (Vascepa, Amarin).
FDA Approves Amgen’s Infliximab-axxq
Biosimilar to Remicade
Ubrogepant Shows Effective Elimination of Migraine Pain and Symptoms
Allergan’s positive phase 3 trial results indicate a potential use for the CGRP receptor agonist.
FDA Approves Acalabrutinib for CLL, SLL
Recent approval under new international Project Orbis.
Givosiran Approved for Acute Hepatic Porphyria
Ultra-rare, potentially life-threatening genetic disease.
Voxelotor Tablets for Sickle Cell Disease Granted Accelerated Approval by FDA
Hemoglobin S Polymerization inhibitor oral treatment.
FDA Approves Cenobamate for Partial-Onset Seizures
Approved for patients 18 years of age and older
FDA Approves Cefiderocol for cUTIs in Adults
Antibiotic with a novel penetrative mechanism.
Pfizer Gains FDA Approval for Humira Biosimilar
Expected U.S. launch in 2023.
Crizanlizumab for Sickle Cell Pain Reduction Approved by FDA
First and currently only biological targeting P-selectin.
FDA Approves Zanubrutinib for Mantle Cell Lymphoma
MCL is an aggressive form of NHL
FDA Approves Luspaterecpt-aamt for Anemia
Shown to reduce regular RBC transfusions in adults with beta thalassemia.
New Filgrastim Biosimilar Approved by FDA
Fourth filgrastim biosimilar from Sandoz, expected ASAP.
Quadrivalent Flu Vaccine Approved for Elders
Approved for ages 65 and older.
FDA Approves Talicia for Helicobacter pylori Infections
First and currently only rifabutin-based H. pylori therapy approved.
