Aflibercept 16-Week Dosing Regimen for Diabetic Retinopathy Under Review
The sBLA is supported by data from the phase 3 PANORAMA trial and the NIH-sponsored Protocol W trial.
Author: Steve Duffy
Novel Oral Drug Combo Fast Tracked for Obstructive Sleep Apnea
The Food and Drug Administration (FDA) has granted Fast Track designation to AD109 for the treatment of obstructive sleep apnea (OSA). AD109 is an investigational, first-in-class, oral medication that contains atomoxetine, a selective norepinephrine reuptake…
Cannabis-Derived Oromucosal Spray Misses in MS Spasticity Trial
Topline results were announced from a phase 3 trial evaluating the efficacy and safety of nabiximols oromucosal spray (JZP378) on clinical measures of spasticity in adults with multiple sclerosis. Nabiximols oromucosal spray is an investigational…
FDA Needs More Data on Tebipenem HBr for Complicated UTI
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Spero Therapeutics regarding the New Drug Application (NDA) for tebipenem HBr (tebipenem pivoxil hydrobromide) for the treatment of adults with complicated…
Pfizer-BioNTech Omicron-Adapted COVID-19 Vaccine Candidates Elicit Strong Immune Response
Pfizer and BioNTech announced positive findings from a study evaluating 2 Omicron-adapted COVID-19 vaccine candidates. The phase 2/3 trial assessed the safety, tolerability, and immunogenicity of a booster (fourth) dose of an Omicron-adapted monovalent vaccine…
Breyanzi Approved as Second-Line Treatment for Large B-Cell Lymphoma
The Food and Drug Administration (FDA) has approved Breyanzi® (lisocabtagene maraleucel) for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from…
FDA: JUUL E-Cigarette Products Banned in US
The Food and Drug Administration (FDA) has ordered JUUL Labs Inc to stop selling and distributing its electronic nicotine delivery system (ENDS) in the US. The banned products include the JUUL device and 4 types…
OTC Laxative Recalled Due to Microbial Contamination
Vi-Jon, LLC is voluntarily recalling 1 lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 fl oz (296mL) due to microbial contamination with Gluconacetobacter liquefaciens, a Gram-negative bacterium. The affected product lot…
Tafinlar-Mekinist Combo Wins Tumor-Agnostic Indication for BRAF V600E Solid Tumors
The Food and Drug Administration (FDA) has granted accelerated approval to Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of individuals 6 years of age and older with unresectable or metastatic solid tumors with BRAF…
Vaccine Candidate Gets Orphan Drug Status for Glioblastoma Treatment
The Food and Drug Administration (FDA) has granted Orphan Drug designation to VBI-1901 for the treatment of glioblastoma. Glioblastoma is a rare, aggressive, malignant grade IV brain tumor that develops from the glial cells. VBI-1901…