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Roche Alzheimers Drug Misses in 2 Phase 3 Studies

[ Price : $8.95]

Roche says results from two Phase 3 studies evaluating Alzheimers therapy gantenerumab were not statistically significant in slowi...

Guide on Device Definition in Regulatory Documents

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Referencing the Definition of a Device in the Federal Food,...

Regulatory Review Period for Mercks Prevymis

[ Price : $8.95]

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Mercks Prevymis (leter...

Guide on Biotech Product Viral Safety Evaluations

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Federal Register notice: FDA makes available a draft guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products D...

Satsuma Plans Migraine NDA After Data Miss

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Satsuma Pharmaceuticals says topline results from the STS101 SUMMIT Phase 3 efficacy trial showed numerical differences in favor o...

ImmunoGens Elahere OKd for Several Cancers

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FDA grants ImmunoGen an accelerated approval for Elahere (mirvetuximab soravtansine-gynx) for treating certain adult patients with...

Insulet Device Correction on Melting Omnipod 5

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Insulet issues a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System because of an overheating issue wit...

Regulatory Review Period for Mercks Prevymis

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Mercks Prevymis (letermovir...

Info Collection on Social/Behavioral Research

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Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Social and Behavioral Resea...

Comment Period Extended on IRB Proposed Rules

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Federal Register notice: FDA extends by two months the comment period on two proposed rules that appeared in the 9/28 Federal Regi...