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Gilead Resubmits NDA for HIV Therapy

[ Price : $8.95]

Gilead Sciences refiles an NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for treating HIV-1 infecti...

Panel Recommends Omicron-based Covid Booster Vaccines

[ Price : $8.95]

FDAs Vaccines and Related Biological Products Advisory Committee votes 19 to 2 to recommend that the SARS-CoV-2 strain composition...

Guide on Bladder Cancer Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant...

Guide on Renal Cell Carcinoma Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Ad...

FDA Complete Response Letter for Spero NDA

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An FDA complete response letter says a Spero Therapeutics NDA for tebipenem HBr tablets to treat adults with complicated urinary t...

Multiple Violations at Re-Gen Active Lab

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FDA warns Irving, TX-based Re-Gen Active Lab about multiple violations in its production and marketing of several cellular-based d...

API Deviations Seen in Fagron Group Inspection

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FDA warns St. Paul, MN-based Fagron Group about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Info Collection on Pilot Survey for Health Projects

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Federal Register notice: FDA sends to OMB an information collection entitled Pilot Survey to Develop Standardized Reporting Forms ...

OTC Drug Proposal to Offer New Class of Products

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FDA proposes to expand options for drug companies seeking to market a nonprescription drug product to allow an additional conditio...

AbbVie Redeemed Priority Voucher for Rinvoq sNDA

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Federal Register notice: FDA announces that AbbVie had redeemed a priority review voucher to gain its 3/16 approval of a supplemen...