BOSTON (

TheStreet

) -- Here's an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012 and into early 2013.

The calendar on the following pages captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between July and February 2013. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst.

Amarin

(AMRN) - Get Amarin Corporation Plc Sponsored ADR Report

Drug/indication:

Vascepa for triglyceride reduction

Approval decision date:

July 26

Horizon Pharmaceuticals

(HZNP) - Get Horizon Therapeutics Public Limited Company Report

Drug/indication:

Lodotra for rheumatoid arthritis pain

Approval decision date:

July 26

Salix Pharmaceuticals

(SLXP)

and

Progenics

(PGNX) - Get Progenics Pharmaceuticals, Inc. Report

Drug/indication:

Relistor SC for opioid-induced constipation

Approval decision date:

July 27

This is an additional indication for currently approved Relistor.

Regeneron Pharmaceuticals

(REGN) - Get Regeneron Pharmaceuticals, Inc. Report

Drug/indication:

Arcalyst for prevention of gout flares

Approval decision date:

July 30

This will be the second approved indication for Arcalyst, which is currently marketed as a treatment for cryopyrin-associated periodic syndromes (CAPS).

Regeneron Pharmaceuticals

(REGN) - Get Regeneron Pharmaceuticals, Inc. Report

and

Sanofi

(SNY) - Get Sanofi Sponsored ADR Report

Drug/indication:

Zaltrap for colon cancer

Approval decision date:

Aug. 4

Zaltrap has posted mixed results in phase III clinical trials.

Talon Therapeutics

( TLON)

Drug/indication:

Marqibo for advanced acute lymphoblastic leukemia

Approval decision date:

Aug. 12

In March, an FDA advisory panel voted to recommend approval of Marqibo.

Gilead Sciences

(GILD) - Get Gilead Sciences, Inc. (GILD) Report

Drug/indication:

Quad for HIV

Approval decision date:

Aug. 27

Quad combines four Gilead drugs into a single, once-daily pill for HIV. The new (and still experimental) components in the Quad are the integrase inhibitor elvitegravir and cobicistat, which is used to boost blood levels of elvitegravir.

Pfizer

(PFE) - Get Pfizer Inc. Report

Drug/indication:

Tofacitinib for rheumatoid arthritis

Approval decision date:

August (exact date not specified)

Tofacitinib would be the first pill approved for the treatment of rheumatoid arthritis, competing with established injectable drugs like Abbbot's Humira.

Ironwood Pharmaceuticals

(IRWD) - Get Ironwood Pharmaceuticals, Inc. Class A Report

Drug/indication:

Linaclotide for chronic idiopathic constipation and irritable bowel syndrome

Approval decision date:

Sept. 8

Navidea Biopharmaceuticals

(NAVB) - Get Navidea Biopharmaceuticals, Inc. Report

Drug/indication:

Lymphoseek, a radioactive tracing agent for lymph node mapping

Approval decision date:

Sept. 10

Regeneron Pharmaceuticals

(REGN) - Get Regeneron Pharmaceuticals, Inc. Report

Drug/indication:

Eylea for Retinal Vein Occlusion (RVO)

Approval decision date:

Sept. 21

This is an additional indication for currently approved Eylea.

NPS Pharmaceuticals

(NPSP)

Drug/indication:

Gattex for short bowel syndrome

Approval decision date:

Sept. 28

Sanofi

(SNY) - Get Sanofi Sponsored ADR Report

Drug/indication:

Aubagio for multiple sclerosis

Approval decision date:

Third quarter

Celgene

Drug/indication:

Abraxane for non-small cell lung cancer

Approval decision date:

Oct. 12

Abraxane is already approved for the treatment of breast cancer.

Santarus

(SNTS)

Drug/indication:

Uceris for ulcerative colitis

Approval decision date:

Oct. 16

TheStreet Recommends

Impax Labs

(IPAX)

Drug/indication:

IPX066 for Parkinson's disease

Approval decision date:

Oct. 19

United Therapeutics

(UTHR) - Get United Therapeutics Corporation Report

Drug/indication:

Oral Remodulin for pulmonary arterial hypertension

Approval decision date:

Oct. 26

Cornerstone Therapeutics

(CRTX) - Get Cortexyme, Inc. Report

Drug/indication:

Lixivaptan for hyponatremia

Approval decision date:

Oct. 29

Medivation

(MDVN)

and

Astellas

Drug/indication:

MDV3100 for prostate cancer

Approval decision date:

Nov. 21

Exelixis

(EXEL) - Get Exelixis, Inc. Report

Drug/indication:

Cabozantinib for medullary thyroid cancer

Approval decision date:

Nov. 29

Alexza Pharmaceuticals

(ALXA)

Drug/indication:

Adasuve for agitation due to schizophrenia

Approval decision date:

Dec. 21

This is Alexza's third attempt at Adasuve approval.

Aegerion Pharmaceuticals

(AEGR)

Drug/indication:

Lomitapide for dyslipidemia/hypercholesterolemia

Approval decision date:

Dec. 28

Biogen Idec

(BIIB) - Get Biogen Inc. Report

Drug/indication:

BG-12 for multiple sclerosis

Approval decision date:

Dec. 28

BG-12 would be Biogen's first pill for multiple sclerosis.

NuPathe

(PATH) - Get UIPATH INC Report

Drug/indication:

Zelrix for migraine

Approval decision date:

Jan. 16, 2013

This is NuPathe's second attempt at Zelrix approval.

Sanofi

and

Isis Pharmaceuticals

(ISIS)

Drug/indication:

Kynamro for hypercholesterolemia

Approval decision date:

Jan. 29, 2013

Raptor Pharmaceutical

(RPTP)

Drug/indication:

RP103 for cystinosis

Approval decision date:

Jan. 30, 2013.

Celgene

(CELG) - Get Celgene Corporation Report

Drug/indication:

Pomalidomide for multiple myeloma

Approval decision date:

Feb. 10, 2013.

Dynavax

(DVAX) - Get Dynavax Technologies Corporation Report

Drug/indication:

Heplisav for hepatitis B prevention

Approval decision date:

Feb. 24, 2013

Sources: Company reports,

TheStreet

research,

BioMedTracker.com

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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