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FDA Grants Breakthrough Therapy Designation for Dizal Pharmaceutical's DZD9008 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon20 Insertion prnasia
January 28, 2022
Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment...
FDA issues series of guidances under Drug Competition Action Plan FDA
January 28, 2022
This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review. These guidances are part of our continued efforts to bring greater efficiency and transparency to the generic drug review process...
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...
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...
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).

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