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Labnovation's COVID-19 ART Test Kit, Imported by Clearbridge, is One of the Only Two COVID-19 ART Test Kits in the Philippines Approved by the FDA of the Philippines for Self-Testing PharmaSources.com
January 27, 2022
Asia's integrated healthcare company, Clearbridge Health Limited ("Clearbridge" or the "Company" and together...
Roche gets FDA priority review for Evrysdi to treat SMA in new-borns pharmaceutical-business-review
January 27, 2022
Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) priority review for its Evrysdi...
FDA limits usage of Lilly and Regeneron’s monoclonal antibodies for Covid-19 Pharmaceutical-Technology
January 26, 2022
The move comes after data showed these therapies are highly unlikely to be active against the Omicron variant.
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...

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