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FDA issues complete response letter for Merck’s chronic cough treatment Pharmaceutical-Technology
January 26, 2022
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Merck’s (MSD) New Drug Application (NDA) for gefapixant to treat adults with refractory chronic cough (RCC) or unexplained chronic cough (UCC).
FDA Purchases Software from Waters to Support its Medical Testing Labs contractpharma
January 26, 2022
Will speed data retrieval, automate essential audit and archival functions, and ensure compliance with legislative mandates.
FDA Halts Use of Regeneron, Lilly COVID Antibody Therapies contractpharma
January 25, 2022
Cites the therapies are less able to target Omicron because of its mutations.
US FDA approves second indication for Skyrizi to treat adults with active psoriatic arthritis ExpressPharma
January 24, 2022
AbbVie recently announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA)...
Audits in the time of COVID-19 – Implications for a CMO CPhIonline
January 24, 2022
Travel restrictions imposed by the pandemic have limited the ability of pharmaceutical companies and health authority personnel to travel and conduct in-person inspections of contract manufacturing organizations (CMOs).
FDA approves Applied Pharmaceutical’s IND application for APS03118 pharmaceutical-business-review
January 24, 2022
The US Food and Drug Administration (FDA) has approved investigational new drug (IND) application for Applied Pharmaceutical Science’s next ...
FDA Limits Use of Two COVID Antibody Treatments drugs.com
January 24, 2022
The U.S. Food and Drug Administration is curtailing the use of two monoclonal antibody treatments that do not appear to work...
Regulus Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA for RGLS8429 FirstWordPharma
January 21, 2022
Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that the Company...
Zydus receives final approval from US FDA for Vigabatrin tablets ExpressPharma
January 21, 2022
Vigabatrin is used to treat babies, one month to two years old with infantile spasms.
WuXi STA Opens Its First Parental Formulation Manufacturing Line contractpharma
January 21, 2022
Features multiple filling modules and a built-in lyophilizer to fill vials, syringes, and cartridges, as well as to produce lyophilized powders.

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