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Ipilimumab Receives FDA Priority Review Designation For Adult Patients With Previously Treated Advanced Melanoma

Main Category: Melanoma / Skin Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Dermatology
Article Date: 20 Aug 2010 – 1:00 PDT

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Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted, for [...]

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Adult Acne Treatments

The initial step to successful adult acne treatment is to realize that you are no longer a teenager and the treatment solutions that worked for you then may not work now. Adult acne is annoying especially when the cause is tough. Try your best to understand why you are susceptible to acne.
No matter how long [...]

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Theravance And Astellas Announce The Commercial Launch Of VIBATIVTM (telavancin) In The United States

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today the commercial launch of VIBATIV™ (telavancin) in the United States. On September 11, 2009, the U.S. Food and Drug Administration (FDA) approved VIBATIV for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus [...]

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Theravance And Astellas Announce FDA Approval Of VIBATIVTM (telavancin) For The Treatment Of Complicated Skin And Skin Structure Infections

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

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FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application By Three Months

Centocor Ortho Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA(TM) (ustekinumab) to provide time for a full review of an amendment to the pending application. The application seeks approval to market STELARA for the treatment of [...]

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