Novartis grabs early FDA approval of lung cancer drug Zykadia

John Carroll After a quick march through the clinic, Novartis has won early FDA approval for the new "breakthrough" lung cancer drug ceritinib (or LDK378), which will now ...

Merck bags FDA approval for its grass pollen pill

Damian Garde Merck picked up an expected FDA approval for the first of three immunotherapies in its allergy pipeline, gearing up to launch a grass pollen-fighting treatment with hopes ...

Celgene wins FDA approval for its blockbuster arthritis contender

Damian Garde Celgene picked up the FDA's blessing for the much-debated apremilast, winning approval to market the oral drug as a treatment for psoriatic arthritis in step one of ...

J&J, Pharmacyclics get CLL approval for Imbruvica

Eric Palmer Johnson & Johnson and Pharmacyclics' new drug Imbruvica won the expanded approval it needed to go beyond a rare disease treatment and reach the blockbuster status ...

Novo nabs FDA approval of a new drug for rare blood clotting disorder

John Carroll Novo Nordisk is ending the year with an approval from the FDA. The agency announced yesterday that it is giving the green light to a new therapy dubbed Tretten to treat ...

Actelion gets second boost for Opsumit with EU approval

Eric Palmer The Swiss drugmaker said in a statement that the EC approved the drug for use by itself or in concert with another PAH drug. Actelion intends to begin selling it in Europe ...

GlaxoSmithKline bags FDA approval for blockbuster COPD contender

Damian Garde GlaxoSmithKline and Theravance scored another victory through their profitable partnership, winning FDA approval for Anoro Ellipta, a trailblazing COPD combo therapy with ...

Bill would fast-track promising antibiotics for FDA approval

Emily Mullin A group of bipartisan members in the House of Representatives introduced a bill late Thursday that aims to combat the growing threat of so-called "superbugs" ...

Gilead prepares for anticipated hep C drug approval with plant expansion

Carly Helfand If the FDA takes the recommendation from a panel that voted 15-0 last week to approve hep C treatment sofosbuvir, maker Gilead will be ready. FiercePharma News

Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit

John Carroll Late on Friday the FDA came through with an approval for Actelion's pulmonary arterial hypertension drug Opsumit (macitentan), its next-gen successor to the franchise ...

Actelion gets FDA approval for Opsumit, follow-up PAH drug to its Tracleer

Eric Palmer Actelion has been anxiously awaiting FDA approval of its new pulmonary arterial hypertension treatment Opsumit, a follow-up to its only significant product, Tracleer, which ...

Bayer wins key FDA approval for lung disease drug Adempas

John Carroll Just hours after Bayer laid out some ambitious plans to accelerate development of a new wave of cancer and cardiovascular therapies, the FDA came through with a key new ...
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