Approvals

FDA

FDA Action Alert: Theravance’s Approval, Mallinckrodt and Aquestive

The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.

November 9, 2018

3 min read

Mark Terry

Why Bristol-Myers' Future is Highly Dependent on T

FDA

BMS’ Empliciti Garners a New FDA Indication for Multiple Myeloma

Joseph Eid, head of medical at BMS, said Empliciti in combination with pomalidomide and dexamethasone has provided proof that the medication can extend the time a patient can live without the worsening of his or her disease.

November 7, 2018

3 min read

Alex Keown

3d illustration of a cancer cell and lymphocytes

FDA

Drug Approvals for the 2 Most Common Types of Cancer in the Last 2 Years

According to the American Cancer Society, almost 601,000 people in the U.S. died of cancer in 2017. The two most common types of cancer are lung cancer and breast cancer, followed by colorectal cancer, prostate cancer and stomach cancer.

November 5, 2018

5 min read

Mark Terry

FDA

FDA Commissioner Outlines Reasons Why a Powerful Opioid Pain Treatment Was Approved

Two days after the FDA approved a powerful new sublingual opioid medication, FDA Commissioner Scott Gottlieb used his Twitter account to defend the approval amid concerns that the medication is susceptible to abuse.

November 5, 2018

3 min read

Alex Keown

FDA

FDA Gives Pfizer’s Lorbrena Thumbs-up for ALK Mutation Lung Cancer

The U.S. FDA approved Pfizer’s Lorbrena (lorlatinib) for ALK-positive metastatic non-small cell lung cancer (NSCLC) in patients whose disease hasn’t progressed on crizotinib and at least one other ALK inhibitor or for patients whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor.

November 5, 2018

2 min read

Mark Terry

FDA

FDA Action Alert: EyePoint Pharma and Merck

Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.

November 2, 2018

3 min read

Mark Terry

FDA

FDA Approves Humira Biosimilar That Won’t Be Available Until 2023

The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.

November 1, 2018

2 min read

Alex Keown

FDA

FDA Greenlights Another Indication for Merck’s Keytruda

Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration. The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.

October 31, 2018

2 min read

Alex Keown

FDA

FDA Approves New SynchroMed(TM) II myPTM(TM) Personal Therapy Manager That Enables Patients to Alleviate Unpredictable Pain

myPTM Allows Patients to Personalize Their Treatment by Delivering On-Demand Boluses, or Drug Doses, Within Therapeutic Limits Set by Their Physician

October 30, 2018

6 min read

FDA

Medtronic Receives FDA Approval for Valiant Navion(TM) Thoracic Stent Graft System

Next-Generation Thoracic Endovascular Repair (TEVAR) Device Expands Applicability to Broader Range of Patients

October 30, 2018