Gilead wins FDA approval for its hep C combo pill, a blockbuster in the making

Damian Garde Gilead Sciences picked up a much-anticipated FDA approval for Harvoni, a combination therapy for hepatitis C that promises to cure the majority of patients without the ...

Lilly says with new data, it will seek another approval for Cyramza next year

Eric Palmer Eli Lilly has harbored big hopes for its newly approved cancer fighter Cyramza. It expects it to get a string approvals, and with new data in hand, it said it will go to ...

Survival miss for Amgen’s Kyprolis may hurt approval chances in Europe

Carly Helfand A Phase III late-stage myeloma miss for Amgen's Kyprolis didn't shock analysts, who said the failure was more or less expected when the company announced trial ...

Can Boehringer carve out space in a crowded COPD market with new approval?

Carly Helfand The COPD market has its fair share of contenders, but that's not stopping Boehringer Ingelheim from joining the party. The German drugmaker has nabbed FDA approval ...

Lilly, Boehringer win FDA approval for once-rejected diabetes drug

Damian Garde After a manufacturing issue scuttled their first attempt, Eli Lilly and Boehringer Ingelheim have won the FDA's blessing to market their new diabetes drug, a late entrant ...

Can Gilead break into cancer? With Zydelig approval, it gets its chance

Tracy Staton Armed with a brand-new FDA approval for its blood cancer drug Zydelig (idelalisib), Gilead will take on the oncology market. FiercePharma News

Novo’s blockbuster diabetes combo nears EU approval

Damian Garde A committee of European Medicines Agency advisers is recommending approval for Novo Nordisk's combination of a long-acting insulin and its blockbuster GLP-1 drug Victoza, ...

Puma shares triple on positive PhIII neratinib data, plans to file for approval

John Carroll FierceBiotech News

FDA will hear Sanofi’s second plea for Lemtrada approval

Emily Wasserman On Friday, the FDA accepted Sanofi's supplemental application for its once-rejected multiple sclerosis treatment Lemtrada for consideration, and a 6-month review ...

Amgen’s Vectibix scores first-line approval in wild-KRAS colorectal cancer

John Carroll The FDA has OK'd the use of Amgen's Vectibix as a first-line treatment for wild-type KRAS metastatic colorectal cancer. The agency approved the frontline use of ...

Merck wins FDA approval for a once-vaunted cardio drug

Damian Garde Merck picked up FDA approval for the clot-busting cardio drug vorapaxar, a treatment once billed as a potential warfarin successor before running into some alarming safety ...

GlaxoSmithKline picks up FDA approval for its latest COPD contender

Damian Garde Adding to its string of respiratory victories, GlaxoSmithKline won an FDA nod for Incruse Ellipta, a once-daily COPD inhaler. FierceBiotech News
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS