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GSKs Nucala Approved for Nasal Polyps

[ Price : $8.95]

FDA approves GlaxoSmithKlines Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients ...

FDA OKs Emergent Resumption of Vaccine Production

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FDA says Emergent BioSolutions can resume producing J&J Covid-19 vaccine at its Bayview manufacturing facility.

FDA Approves Mylan Semglee Biosimilar Insulin Product

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FDA approves Mylans Semglee, the first biosimilar and interchangeable insulin product approved in the U.S.

Ceclor Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Eli Lillys Ceclor CD (cefaclor extended-release tablets) 375 mg and 500 mg were not w...

eCTD Validations Effective 9/15: FDA

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Federal Register notice: CDER and CBER announce the effective date of 9/15 for using Electronic Common Technical Document validati...

Efudex Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Bausch Health Americas Efudex (fluorouracil) topical solution, 5%, was not withdrawn ...

Guide on Rabies Monoclonal Antibody Cocktails

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Federal Register notice: FDA makes available a draft guidance entitled Rabies: Developing Monoclonal Antibody Cocktails for the Pa...

HHS Should Allow Some Rx Drug Imports: Senators

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A bipartisan group of four senators asks HHS to pursue policies to allow Americans to import some drugs from Canada.

Dont Criminalize Device Truthful Speech: WLF

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Washington Legal Foundations asks the 1st Circuit Court of Appeals to reverse the conviction of two former medical device executiv...

Allergans Botox Gets Spasticity Expanded Label

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FDA approves an Allergan label expansion for Botox to include eight new muscles for treating upper limb spasticity in adults.