Legal & Regulatory

Trial data show Dupixent is the first and only novel biologic drug to significantly improve lung function and reduce severe acute exacerbations in adults with uncontrolled chronic obstructive pulmonary disease.

Immune-Onc Therapeutics’ IO-202 is currently being analyzed as a monotherapy and in combination for patients with relapsed/refractory acute myeloid leukemia with monocytic differentiation or chronic myelomonocytic leukemia.

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

Phase III results from Keytruda (pembrolizumab)’s NRG-GY018 trial help influence the agency’s decision.

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.

The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle.

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.

Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.

Patients with severe frostbite who were administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation.

Augtyro was previously approved in November 2023 to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) was found to improve overall survival in metastatic pancreatic adenocarcinoma.

Examination evaluates investigational stem cell interventions, including how the states have implemented their own policies when it comes to their uses.

BXCL701 combined with Keytruda (pembrolizumab) is being evaluated for patients with metastatic castration-resistant prostate cancer with small cell neuroendocrine and adenocarcinoma phenotypes.

In clinical trials, bepirovirsen was found to recognize the RNA used by hepatitis B virus to replicate in infected liver cells.

Eohilia, a corticosteroid developed specifically to treat eosinophilic esophagitis, is comprised of a novel formulation of budesonide taken twice daily for 12 weeks in patients 11 years of age and older.

Technavio analysis notes that an increase drug patent expirations could be a contributing factor.

The FDA placed a full clinical hold on magrolimab for hematologic cancers after data showed the drug in combination with azacitidine plus Venclexta increased the risk of death related to infections and respiratory failure in patients with acute myeloid leukemia.

Phase III CheckMate -77T trial data show statistically significant improvements in event-free survival with Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the treatment of resectable stage IIA to IIIB non-small cell lung cancer.

BioNTech SE and Duality Biologics Co's BNT325/DB-1305 is a next-generation antibody-drug conjugate that targets the TROP2 protein, which is overexpressed across various tumor types.

Arexvy was the first FDA-approved respiratory syncytial virus (RSV) vaccine to prevent lower respiratory tract disease caused by RSV in individuals 60 years of age and older.