fbpx
May 15, 2020

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line […]
May 15, 2020

Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Docket Number: FDA-2001-D-0164 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to address […]
May 15, 2020

Q1C Stability Testing for New Dosage Forms

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This document is an annex to the ICH Harmonized […]
May 15, 2020

Q1B Photostability Testing of New Drug Substances and Products

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The ICH Harmonized Tripartite Guideline on Stability Testing of […]
May 15, 2020

Q1A(R2) Stability Testing of New Drug Substances and Products

Docket Number: FDA-2002-D-0222 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is the second revision […]
May 15, 2020

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase (Alteplase) 100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection

Summary Company Announcement Date: September 06, 2017 FDA Publish Date: February 08, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Lack of […]
May 15, 2020

Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential For Lack of Sterility Assurance

Summary Company Announcement Date: June 23, 2017 FDA Publish Date: February 08, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Lack of Sterility […]
May 15, 2020

Endo Pharmaceuticals Inc. Issues Voluntary Nationwide Recall for One Lot of Edex® (alprostadil for injection) 10 mcg 2 Pack Carton Due to Potential Lack of Sterility Assurance

Summary Company Announcement Date: February 24, 2017 FDA Publish Date: February 08, 2018 Product Type: DrugsFood & BeveragesGeneric Drugs Reason for Announcement: Recall Reason Description Potential […]
May 15, 2020

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

On May 14, 2020, the Food and Drug Administration expanded the indication of pomalidomide (POMALYST, Celgene Corporation) to include treating adult patients with AIDS-related Kaposi sarcoma […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0