• Takeda,VELCADE,bortezomib,multiple myeloma,Millennium

The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE? (bortezomib) for the retreatment of adult patients with multiple myeloma (MM)

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  • INVOKAMET,FDA,Janssen Pharmaceuticals,Treatment

Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKAMET?, a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes.

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  • multiple sclerosis,MS,Tecfidera,Decision Resources Group

Decision Resources Group finds that the forecast launch of Biogen Idec's Plegridy, Roche/Genentech's ocrelizumab, Biogen Idec/AbbVie's daclizumab, Teva/Active Biotech's Nerventra and Receptos' RPC-1063, coupled with the expected U.S.

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  • Sovaldi ,India,Gilead,99% discount,$84,000

The $84,000 U.S. treatment price that Gilead Sciences ($GILD) is charging for its hepatitis C drug Sovaldi has elicited pleas from politicians and threats from payers, who say the U.S. healthcare system cannot bear the cost.

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  • ABRAXANE,metastatic pancreatic cancer,Pancreatic Cancer,

Health Canada has approved PrABRAXANE for Injectable Suspension for first-line treatment of adult patients with metastatic pancreatic cancer. The approval is welcome news for Canadians who are diagnosed with metastatic pancreatic cancer, and represents the first approved treatment for this disease in nearly two decades.

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  • Medicines,ORBACTIV,oritavancin,Skin Structure Infections,Bacterial Skin

FDA Approves The Medicines Company's ORBACTIV? (oritavancin) for Use in Acute Bacterial Skin and Skin Structure Infections First and Only Single Dose Antibiotic for the Treatment of Skin Infections Caused by Susceptible Designated Gram-positive Bacteria ORBACTIV?U.S. Launch Expected in 2H/2014

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  • AbbVie,ABT-414,Orphan Drug Designation,Glioblastoma Multiforme,AbbVie Oncology

AbbVie today announced the EMA and FDA have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme.

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  • Baxter,FLEXBUMIN,5% Human Albumin Solution,Flexible Container

Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved FLEXBUMIN? [Albumin (Human)], USP, 5% Solution.

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Recent News

Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.

First data backs efficacy of BMS' novel HIV drug

A Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.

EU Rules Could Restrict Genetic Testing

Genetic testing describes the application of laboratory methods to look at a person’s genes (the inherited DNA instructions). Genetic tests can be used to diagnose a genetic condition; screen for a risk of developing a particular health problems; for the selection of treatments; or to assess responses to treatments.

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection

FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.