January 9, 2020
January 9, 2020 – The U.S. FDA has approved AyvakitTM (avapritinib), manufactured by Blueprint Medicines Corporation, to treat adult patients who have unresectable or metastatic gastrointestinal
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January 8, 2020
January 8, 2020 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck, to treat patients who are ineligible for or have elected not to undergo cystectomy and have been diagnosed with high-risk, non-muscle invasive bladder cancer (NMIBC)
January 8, 2020
January 8, 2020 – Several products used to treat gastrointestinal (GI) conditions have been voluntarily
recalled due to the presence or potential presence of N-nitrosodimethylamine (NDMA). NDMA is a known
environmental contaminant found in food and water and is considered a probable human
January 6, 2020
January 6, 2020 – Pfizer has announced the launch of ZirabevTM (bevacizumab-bvzr), its biosimilar for Genentech’s Avastin® (bevacizumab). Zirabev is indicated to treat certain patients who have cervical cancer, colorectal cancer, glioblastoma, non-squamous non-small cell lung cancer (NSCLC)
December 31, 2019
December 31, 2019 –Aurobindo Pharma has announced a voluntary recall of one lot of Mirtazapine
Tablets due to a labeling error. Bottles belonging to lot number 03119002A3 may be labeled as containing 7.5mg tablets when in fact they contain 15mg tablets.
December 31, 2019
December 31, 2019 –The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca Pharmaceuticals. The product is now indicated to provide first-line maintenance
treatment for patients who have deleterious or suspected deleterious gBRCAm
December 26, 2019
December 26, 2019 –The U.S. FDA has approved updates to the product label for Zilretta® (triamcinolone
acetonide extended release injectable suspension), manufactured by Flexion Therapeutics. Zilretta is a
synthetic corticosteroid indicated for use as an intra-articular injection to manage osteoarthritis pain
December 26, 2019
December 26, 2019 –The U.S. FDA has approved an expanded indication for Fiasp® (insulin aspart
injection), manufactured by Novo Nordisk. Originally approved in 2017 to improve glycemic control in adults who have diabetes mellitus, the product is now also approved to treat pediatric patients.