Companies seeking approval for new drugs or biologics must navigate the clinical trials process, which can take over a decade and hundreds of millions of dollars to complete. Only a small fraction of compounds discovered in the preclinical stage will go on to received FDA approval, and in recent years the agency has become even more rigorous in its reviews.

Phases of drug development
In the pre-clinical or drug discovery phase of the approval process, researchers look for potential new compounds to treat targeted diseases. Promising compounds are tested in animals and living tissue until they are refined enough to give to humans. When all tests are completed, the drugmakers file an investigational New Drug Application (IND) with the FDA. In Phase I testing, the new drug is given to a small group of healthy people to see if the drug is safe and well-tolerated. Safe drugs are advanced into Phase II trials, where companies see if their compound is actually effective in a small number of people who have the disease they're targeting. If evidence of efficacy is observed, the drug is moved into large-scale Phase III studies. Positive results at this stage prompt drugmakers to file a New Drug Application (NDA) or Biologics License Application (BLA). An expert panel reviews all the trial data and makes a recommendation to the FDA, which in turn decides whether or not to grant approval.

Low rate of new-drug approval
Following a string of high-profile recalls and safety warnings, the FDA is increasingly rigorous in the review process. As a result, fewer drugs are being approved. Only 21 new drugs got the green light in 2010--fewer than both 2009 and 2008, when 25 and 24 were approved, respectively. However, 2010 was better than 2007, when regulators just 18 medicines-an all-time low. The agency is particularly focused on drug safety. Regulators also want to see evidence that new drugs not only work, but offer real benefits compared to older and less-expensive medications already on the market. Oncology and obesity drugs face the most scrutiny from the agency, while large molecule drugs (biologics) are twice as likely to be approved than than small molecule drugs.

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FDA approval

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Neos wins FDA approval for a melts-in-your-mouth take on Adderall for ADHD

Neos Therapeutics, at work on extended-release versions of old drugs, won FDA approval for a long-acting ADHD pill that dissolves in patients' mouths.

Roche wins FDA approval for a new lung cancer drug

Roche picked up an accelerated FDA approval for its latest lung cancer therapy, planning to market the treatment for severely ill patients while building the clinical case for wider use.

Otonomy wins FDA approval for a first-of-its-kind ear treatment

Otonomy won FDA approval for its first product, a one-time ear treatment designed to reduce complications after tube placement, and the small biotech is gearing up to launch the product on its own.

UPDATED: Alexion grabs an FDA OK--the 41st of '15--for rare-disease drug Kanuma

Seven months after Alexion bagged the rare-disease drug Kanuma in its $8.4 billion buyout of Synageva, the FDA has come through with a marketing approval. The agency has now approved 41 new therapies in 2015, matching the chart-topping record for all of last year.

Adapt Pharma earns FDA approval of first intranasal spray for emergency opioid overdose

Adapt Pharma's Narcan nasal spray became the first noninjectable treatment for opioid overdose emergencies thanks to its FDA approval on Nov. 19.

Gilead wins FDA approval for a new HIV combo pill with rivals at its heels

Gilead Sciences won FDA approval for another combination tablet designed to keep HIV from replicating itself, a drug the company touts as a safer alternative to products already on the market.

Alkermes wins an FDA nod for its monthly schizophrenia drug

Alkermes picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.

Allergan and Richter's antipsychotic gets FDA OK but faces stiff competition

On Thursday, Allergan snagged FDA approval for a sort-of-new antipsychotic, Vraylar, to treat schizophrenia and bipolar disorder in adults. But after about a two-year delay in which a raft of antipsychotics--both generic and branded--have made it to market, the question is where it will find a place of its own.

Amicus plots an end-of-year FDA filing for its resuscitated lead drug

Amicus Therapeutics, fresh off reviving a once-failed drug, has reached an accord with U.S. regulators and is on track to submit its rare disease treatment for FDA approval before the end of this year.

Wright Medical gains on FDA approval of Augment Bone Graft

Orthopedic specialist Wright Medical is up almost 10% to a $1.2 billion valuation in early trading on the news that its Augment Bone Graft has been granted a PMA approval. It's slated for use as an alternative to auto-graft for ankle or hind-foot fusion indications.
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