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Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14 PR Newswire
March 24, 2025
EVM14 received U.S. FDA clearance for its IND application, becoming Everest's first internally discovered program, and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development.
Illuccix? Receives European Approval PharmaSources
January 21, 2025
Telix announces positive MAA decision for Illuccix in Europe via DCP, a key step for its commercial launch in treating prostate cancer.
Sandoz Recalls One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping AmericanPharmaceuticalReview
December 09, 2021
Sandoz Inc. is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin.
Sagent Pharmaceuticals Recalls Levetiracetam Injection, USP Due to Lack of Sterility Assurance AmericanPharmaceuticalReview
December 01, 2021
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product.
Mylan Initiates Recall of One Lot of Daptomycin for Injection americanpharmaceuticalreview
July 20, 2020
Mylan announced its U.S.-based Mylan Institutional business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in ...
BeiGene submits application for the fifth indication for Tislelizumab Injection PharmaSources/Xiaoyaowan
June 30, 2020
On June 29, the official website of CDE showed that the PD-1 antibody of BeiGene submitted a new indication application for Tislelizumab injection and was accepted.
Fresenius Kabi Expands MicroVault Packaging contractpharma
June 24, 2020
Simplist MicroVault packaging supports diversion deterrence and secure dispensing of controlled substances.
Novadoz Increases Receives FDA Approval of Thiotepa Vials for Injection americanpharmaceuticalreview
March 09, 2020
Novadoz Pharmaceuticals received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.
Eton Announces Commercial Availability of Biorphen Injection americanpharmaceuticalreview
December 30, 2019
Eton Pharmaceuticals announced Biorphen?, the first and only FDA-approved ready-to-use formulation of phenylephrine for the treatment of clinically important hypotension ...
The injection consistency evaluation may be comprehensively implemented as the NMPA takes frequent actions (1) PharmaSources/zhulikou431
November 14, 2019
Technicians of pharmaceutical enterprises have significantly more to learn in the second half of 2019 with the promulgation of the Drug Administration Law (2019 Revision).