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Federal Register

Guide on Biotech Product Viral Safety Evaluations

Federal Register notice: FDA makes available a draft guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lin...

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Human Drugs

Satsuma Plans Migraine NDA After Data Miss

Satsuma Pharmaceuticals says topline results from the STS101 SUMMIT Phase 3 efficacy trial showed numerical differences in favor of its migraine drug ...

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Biologics

ImmunoGens Elahere OKd for Several Cancers

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

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Medical Devices

Insulet Device Correction on Melting Omnipod 5

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

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Federal Register

Regulatory Review Period for Mercks Prevymis

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

Federal Register

Info Collection on Social/Behavioral Research

Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Social and Behavioral Research as Used by the F...

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Federal Register

Comment Period Extended on IRB Proposed Rules

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

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Human Drugs

GSK Narrows Zejula Indication at FDAs Request

GSK says it has complied with an FDA request to restrict the second-line maintenance indication for cancer drug Zejula (niraparib).

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Human Drugs

FTC Takes Issue with Jazz Orange Book Listing

The FTC files an amicus brief with the Delaware federal court in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, taking issue with a J...

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Human Drugs

Imfinzi/Imjudo OKd for Lung Cancer

FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for treating adults with Sta...