Struggling Eisai gets FDA approval for cancer drug Halaven for liposarcoma

Eric Palmer Japan's Eisai got a much-needed boost on Thursday when the FDA approved its cancer drug, Halaven, for treatment of liposarcoma for patients in which the cancer has advanced ...

Merck lines up for a quick approval with its C. diff therapy

Damian Garde Merck is nearing FDA approval for its Clostridium difficile-fighting antibody, picking up the agency's priority review designation with the promise of a shortened vetting ...

Amgen’s Humira biosim is one step closer to FDA approval. But how close is it to market?

Carly Helfand On Monday, Amgen said the FDA had accepted its application for its biosimilar of AbbVie's Humira, so-called ABP 501–but earlier this month, the U.S. Patent ...

Lilly and Incyte shoot for FDA approval with an oral RA drug

Damian Garde Partners Eli Lilly and Incyte filed an oral rheumatoid arthritis treatment for FDA approval, hoping to launch an agent that can steal market share from blockbuster injectables. FierceBiotech ...

Samsung and Biogen win first EU approval for an Enbrel copycat

Damian Garde A joint venture between Biogen and South Korean giant Samsung won Europe's first approval for a lower-cost version of Amgen and Pfizer's blockbuster Enbrel, planning ...

Obama’s pick for FDA chief clears a Senate panel on the way to likely approval

Damian Garde Robert Califf, a Duke University cardiologist in line to become the next FDA commissioner, won over a Senate panel and is on his way to final confirmation, slated to follow ...

Gene therapy player Spark eyes a groundbreaking approval by 2017

Damian Garde Spark Therapeutics, at work on gene therapies for rare diseases, laid out an ambitious three-year plan that would see its top candidate win FDA approval and 9 others enter ...

Roche and AbbVie line up for quick approval for cancer drug venetoclax

Damian Garde Partners Roche and AbbVie are speeding toward FDA approval with a cancer treatment tabbed as a potential blockbuster, picking up a priority review for a blood cancer therapy. FierceBiotech ...

Sanofi gets first approval for long-anticipated vaccine against dengue fever

Eric Palmer After two decades and $ 1.65 billion in research, French drugmaker Sanofi has gotten an approval for the world's first vaccine against the sometimes deadly dengue fever, ...

Baxalta wins FDA approval with a treatment for a rare bleeding disease

Damian Garde Baxalta picked up FDA approval for a drug that treats von Willebrand disease, a rare inherited bleeding disorder that results from a missing protein. FierceBiotech News

Lilly’s middling lung cancer drug wins FDA approval with a restrictive label

Damian Garde Eli Lilly won FDA approval for a lung cancer treatment that posted only a marginal survival benefit in late-stage clinical trials, gaining clearance to treat a small population ...

Takeda’s ‘breakthrough’ Velcade heir wins early FDA approval in myeloma

Damian Garde Takeda Pharmaceutical's top cancer prospect won a speedy FDA approval, wading into a crowded market for multiple myeloma treatments with hopes of duplicating the success ...
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