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U.S. FDA Accepts Regulatory Submission for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Cancer prnasia
May 18, 2021
Innovent Biologics, Inc. and Eli Lilly and Company today jointly announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sintilimab injection in combination with pemetrexed and platinum ...
New harmonised guidance for post-approval changes released by FDA europeanpharmaceuticalreview
May 18, 2021
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
Zynrelef Anesthetic Receives FDA Approval contractpharma
May 18, 2021
Lifecore will manufacture the new innovative drug for treatment of postoperative pain.
Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 americanpharmaceuticalreview
May 17, 2021
Labcorp has announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17.
FDA outlines plan for making inspections more consistent going forward europeanpharmaceuticalreview
May 14, 2021
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products americanpharmaceuticalreview
May 14, 2021
The U.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.”
Growing opportunities in API manufacturing as innovative biologic approvals increase: GlobalData expresspharma
May 13, 2021
The US Food and Drug Administration (FDA) approved more biologic new molecular entities (NMEs) in 2020 than in any other year in the previous decade, while at the same time, sponsors increased the outsourcing of these biologics’ active pharmaceutical ...
FDA Grants Bold Therapeutics' BOLD-100 an Orphan Drug Designation (ODD) in the Treatment of Gastric Cancer americanpharmaceuticalreview
May 12, 2021
Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that the U.S. Food & Drug Administration (FDA) has granted BOLD-100 an Orphan Drug Designation (ODD) in the treatment of gastric (stomach) cancer.
FDA grants fast track designation to Cerecor’s Covid-19 treatment pharmaceutical-technology
May 12, 2021
The US Food and Drug Administration (FDA) has granted fast track designation to Cerecor’s fully human monoclonal antibody (mAb), CERC-002, for treating hospitalised Covid-19 patients.
Pfizer, BioNTech get US FDA nod for emergency use of COVID-19 vaccine in adolescents expresspharma
May 12, 2021
Pfizer and BioNTech SE announced that the US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age.

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