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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine americanpharmaceuticalreview
May 08, 2021
Pfizer Inc. and BioNTech SE have announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
FDA Approves ADC Therapeutics' Zynlonta contractpharma
May 08, 2021
ADC collaborated with CDMO Sterling Pharma Solutions to develop the cancer drug.
FDA Expands Collaboration with CN Bio to Investigate Lung-On-A-Chip Model for Inhaled Drug Evaluation Applications americanpharmaceuticalreview
May 07, 2021
CN Bio, a developer of single- and multi-organ-on-chip microphysiological systems (MPS) that improve the accuracy and efficiency of drug discovery, announced that the U.S. Food and Drug Administration (FDA) has extended their research collaboration ...
Amphastar Pharmaceuticals Receives FDA Approval for Morphine Sulfate Injection americanpharmaceuticalreview
May 07, 2021
Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration approved the company’s Abbreviated New Drug Application (“ANDA”) for Morphine Sulfate injection 1mg/mL in the 30mL Pump-Jet® Prefilled Syringe System.
Hikma Pharma get US FDA nod for higher dosage of nasal spray product to treat opioid overdose expresspharma
May 07, 2021
The US Food and Drug Administration (US FDA) announced the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose.
Hikma get US FDA nod for higher dosage of naloxone nasal spray to treat opioid overdose expresspharma
May 07, 2021
The US Food and Drug Administration (US FDA) announced the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose.
FDA approves AstraZeneca’s Farxiga for chronic kidney disease treatment pharmaceutical-technology
May 06, 2021
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Farxiga (dapagliflozin) for treating chronic kidney disease (CKD) in patients who are at the risk of progression with and without type-2 diabetes.
FDA Takes Action for Failure to Submit Required Clinical Trials Results to Clinicaltrials.gov americanpharmaceuticalreview
April 30, 2021
The FDA has issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) for failing to submit required summary results information to ClinicalTrials.gov.
ADMA Receives FDA Approval for Increased IVIG Production Scale contractpharma
April 30, 2021
ADMA Biologics, an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, has received approval from the FDA for the company’s expanded manufacturing process, enabling ...
FDA Issues Draft Guidance on Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products americanpharmaceuticalreview
April 29, 2021
The U.S. Food and Drug Administration has issued the draft guidance “Nonclinical Testing of Individualized Antisense Oligonucleotide (ASO) Drug Products for Severely Debilitating or Life-Threatening Diseases - Guidance for Sponsor-Investigators.”

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