Trials & Filings
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July 5, 2011
DVT indication brings Lovenox-buster to U.S. market
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June 27, 2011
Submission-ready documentation now provided through Regulatory Services Group
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June 24, 2011
Second complete response letter for ER oxycodone
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June 22, 2011
Cancels NDA and MAA and withdraws MS treatment from approved markets
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June 16, 2011
Bristol-Myers Squibb received approval from the FDA for Nulojix (belatacept) to prevent acute rejection in adult patients who have had a kidney transplant.
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June 15, 2011
Abbott received approval from the FDA for an infant-specific dose of Creon (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
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June 13, 2011
Valeant Pharmaceuticals International and GlaxoSmithKline have received FDA approval for Potiga (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
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June 8, 2011
Merck and Intercell AG have terminated the Phase II/III trial investigating Staphylococcus aureus vaccine, V710, following analysis of the trial data and the unanimous recommendation by an independent Data Monitoring Committee (DMC).
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June 7, 2011
Biogen Idec received approval from the European Commission for its Avonex Pen for patients with relapsing multiple sclerosis (MS) and patients who have had a single demyelinating event.
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May 17, 2011
Pfizer’s NDA for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), has been accepted for filing and granted Priority Review status by the FDA.
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May 9, 2011
Pfizer met all study endpoints in two Phase III immunogenicity and safety trials of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults aged 50 years and older.
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May 4, 2011
Beijing Second Pharmaceutical Co., Ltd. (BSPC) has received FDA approval of its ANDA 090752 for Amlodipine Besylate, a generic form of Pfizer’s Norvasc.
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April 25, 2011
Sanofi Pasteur received approval from the FDA for the expanded use of meningococcal conjugate vaccine Menactra in infants and children 9 to 23 months of age.
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