Topic: Pharmaceutical Labeling

12Sep/18

Chasing top HIV players, Merck scores FDA approval for 2 new drugs

After marquee HIV drug approvals last year for Gilead and GlaxoSmithKline, Merck will follow into the crowded market with two new meds. The drugmaker scored FDA approvals for a new non-nucleoside reverse transcriptase inhibitor calledRead More…

13Aug/18

FDA Grants Breakthrough Therapy Designation For Food Allergy Med

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Genentech’s,Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.Read More…

11Jul/18

Mylan Launches Generic Version Of The Novartis Exelon Patch

Mylan N.V. today announced the U.S. launch of Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, a generic version of Novartis’ Exelon Patch. Mylan received final approval fromRead More…

12Jun/18

FDA Approves Genentech’s Rituxan For Pemphigus Vulgaris

The U.S. Food and Drug Administration (FDA) has approved Genentech’s Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painfulRead More…

14May/18

FDA Grants Priority Review of Genentech’s Tecentriq

Genentech, a member of the Roche Group today announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxelRead More…

16Apr/18

Lonza Opens World’s Largest Dedicated Cell And Gene Therapy Manufacturing Facility

Lonza opened the world’s largest dedicated cell and gene therapy facility, which was built in anticipation of the rising demand from developers of cell and gene therapies—believed to be the next era inRead More…

12Mar/18

Grifols pushes for genetic COPD testing in Rare Disease Day campaign

In rare cases, the lung disease COPD can be genetic. So Wednesday, on Rare Disease Day, Grifols is launching an awareness campaign to encourage COPD patients to get tested. Of the estimated 11 millionRead More…