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Competitive Generic Therapies Guidance

[ Price : $8.95]

FDA publishes a guidance with information on competitive generic therapies.

Glaxo Lung Cancer Phase 2 Trial Meets Endpoint

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GlaxoSmithKline announces positive results from the Phase 2 PERLA trial of its lung cancer drug Jemperli.

No Pre-EUA for Eiger Covid Treatment

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FDA will not hold a pre-EUA meeting with Eigen BioPharmaceuticals on its possible use of peginterferon lambda to treat Covid-19.

Post-CRL Clarification Teleconference Guidance

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FDA publishes a guidance incorporating GDUFA 3 reauthorization performance goals for post-complete response letter clarification t...

Reject Novel Liability Theory for Rx Drugs: WLF

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Washington Legal Foundation says a California trial court erred in ruling that Gilead could be held liable for not developing a di...

4 CBER SOPPs on Application Processing

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CBER publishes four Standard Operating Policies and Procedures relating to application review responsibilities for various product...

Bayer Reiterates Position on Apotex ANDA

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Bayer pushes FDA to confirm that it will grant a 30-month stay before approving an Apotex ANDA for Bayers Astepro Allergy nasal sp...

FDA, NYU Partner on Stroke Rehab Review Tool

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FDA and researchers from New York University partner to design a regulatory science tool to improve the review processes for strok...

FDA Biosimilar Regulatory Science Program Opens

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FDA is soliciting projects to fund under a new pilot program to enhance regulatory science for biosimilars and interchangeable pro...

Manufacturing Woes Lead to Natpara Discontinuation

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Takeda says it will discontinue manufacturing Natpara (parathyroid hormone) for injection due to manufacturing woes that caused pr...