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Gepirone

New Drug Approvals

The FDA rejected approval for gepirone in 2002 and 2004. [5] 5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13]

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2025 Merkin Prize in Biomedical Technology awarded to pioneers of CAR T-cell therapy

Broad Institute

In 2007, Sadelain and Rivire treated their first patient with leukemia, and in 2009, published details on how they manufactured personalized CAR T cells to treat patients with aggressive leukemia. Sadelain and Rivire also developed safe and reliable ways to produce these cells for use in patients.

Therapies 119
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Elacestrant 

New Drug Approvals

2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Jump up to: a b c d e f g “FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer” U.S. Food and Drug Administration (FDA). 8 February 2023. 27 January 2023.

FDA 62
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PRITELIVIR MESYLATE

New Drug Approvals

7] If the virus also acquires resistance to foscarnet, then there is currently no FDA approved treatment. Infectious Diseases Community of Practice (2009). The use of foscarnet is commonly accompanied by restrictive toxicity, particularly nephrotoxicity. [7] 13 (Suppl 4): 121–7. doi : 10.1111/ajt.12105. PMID 23465005.

Virus 62
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Mylan secures first FDA approval for generic version of Biogen's Tecfidera following patent dispute

The Pharma Data

Our commitment to the MS community stems all the way back to our initial investment in 2009 to bring a first generic Copaxone to market, which we achieved in 2017,” commented Mylan President Rajiv Malik. Mylan was quick to celebrate the decision and what it means for MS patients, though no information on the price of the drug was forthcoming.

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FDA approves Novartis’ MS drug Kesimpta for treating relapsed forms of the disease

The Pharma Data

The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider. Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments.

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Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children

The Pharma Data

.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDA approval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers.