FDA finds mystery ‘deficiencies’ with Neos’ long-acting Ritalin on the eve of approval

Damian Garde Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's ...

Boehringer wins FDA approval for its Pradaxa antidote with eyes on a bigger market share

Damian Garde Boehringer Ingelheim picked up an FDA nod for an injection designed to reverse the effects of its blockbuster anticoagulant Pradaxa, marking the first approval for an antidote ...

Takeda rolls toward EU approval with its heir to Velcade

Damian Garde Takeda's top oncology prospect is moving toward approval in the European Union, as continental regulators have accepted the company's application and promised a ...

Esperion surges after FDA offers a shot at quick approval for LDL-lowering drug

John Carroll Shares of Esperion Therapeutics shot up more than 10% after the market closed on Monday–after the biotech tipped off investors that the FDA is not going to require ...

Novartis wins an early approval for a new skin cancer drug

Damian Garde Novartis won accelerated approval for a promising oncology drug, gearing up to launch a new treatment for an advanced form of the most common type of skin cancer. FierceBiotech ...

Intercept files its ‘breakthrough’ liver drug for rare disease approval

Damian Garde Intercept Pharmaceuticals has submitted its top candidate to the FDA for approval in primary biliary cirrhosis, a rare disease that results in serious liver damage. FierceBiotech ...

Medicines Co.’s cangrelor finally lines up for FDA approval

Damian Garde A panel of FDA advisers reversed its earlier derision and voted in favor of the Medicines Company's long-delayed blood thinner, spelling a likely approval for the drug ...

Lilly and Boehringer roll toward EU approval with diabetes combo

Damian Garde Eli Lilly and Boehringer Ingelheim secured a recommendation from European regulators for their combination diabetes treatment, making for a likely continental approval ...

Eisai gets EMA nod for Lenvima just weeks after FDA approval

Eric Palmer Eisai has gotten its second dose of good news in as many months. Weeks after getting an FDA approval for its thyroid cancer drug Lenvima, the struggling Japanese drugmaker ...

Astellas scores FDA approval for life-threatening fungus-fighter

Carly Helfand The FDA offers incentives for developing products that target life-threatening infections, and Astellas just became the latest drugmaker to take advantage. FiercePharma ...

Astellas bags FDA approval for a new anti-infective

Damian Garde Japanese pharma giant Astellas won FDA approval for an anti-fungal treatment targeting two rare but dangerous infections, the latest drugmaker to take advantage of new ...

Novartis bags a surprise approval for the blood cancer-treating panobinostat

Damian Garde Going against the advice of its independent experts, the FDA approved Novartis' new blood cancer drug for patients with particularly deadly forms of multiple myeloma, ...
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