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FDA Approves Novartiss Signifor for Treating Acromegaly

[ Price : $8.95]

FDA approves a Novartis NDA for Signifor (pasireotide) long-acting release for treating patients with acromegaly who have had an i...

Acura Pharma Petitions FDA on Purdue Pain Drug NDA

[ Price : $8.95]

Acura Pharmaceuticals petitions FDA asking it to rescind acceptance of a Purdue Pharma 505(b)(2) NDA that Acura believes was recen...

Genentech NDA Filed for Melanoma Therapy

[ Price : $8.95]

Genentech files an NDA for cobimetinib for treating, in combination with Zelboraf (vemurafenib), patients with BRAF V600 mutation-...

EOS Imaging Hip Arthroplasty Planning Software Approved

[ Price : $8.95]

FDA approves an EOS imaging PMA for its hipEOS, a 3D hip arthroplasty planning software based on EOS stereo-radiographic 2D/3D ima...

Acorda Seeks Tighter Bioequivalence for Generic Ampyra

[ Price : $8.95]

Acorda Therapeutics petitions FDA seeking rigorous bioequivalence requirements for proposed generic copies of its multiple scleros...

Baxter Recalls 2 Sodium Chloride Injection Lots

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Baxter International recalls two lots of 0.9% sodium chloride injection USP in 100 mL Mini-Bag Plus Container after two complaints...

FDA Clears diaDexus Heart Disease Test

[ Price : $8.95]

FDA clears a diaDexus 510(k) for a new screening test that predicts a patients risk of future coronary heart disease events.

FDA Clears Olympus Narrow Band Imaging Technology

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FDA clears an Olympus 510(k) for its Narrow Band Imaging to enable effective targeting of biopsies not seen under white light.

Animal Drug Regs Reflect Sept., Oct. Approvals

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Federal Register Notice: FDA is amending the animal drug regulations to reflect September and October approval actions for NADAs a...

FDA Withdraws Approval of Oxytetracycline ANADA

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Federal Register Notice: FDA withdraws approval of a Vetoquinol ANADA for oxytetracycline hydrochloride soluble powder.