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FDA Provides New Guidance to Further Enhance the Security of Prescription Drugs in U.S. Supply Chain americanpharmaceuticalreview
June 07, 2021
The FDA is finalizing two guidance documents and making available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain.
Glenmark gets US FDA approval for Theophylline ER Tablets, 300 mg and 450 mg expresspharma
June 07, 2021
Granted competitive generic therapy (CGT) designation and is eligible for 180 days of CGT exclusivity on the 450 mg.
FDA Approves Novartis Cosentyx for Children with Plaque Psoriasis americanpharmaceuticalreview
June 04, 2021
Novartis, a leader in immuno-dermatology and rheumatology, announced that the FDA has approved Cosentyx® (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic ...
FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma americanpharmaceuticalreview
June 04, 2021
The FDA granted accelerated approval to infigratinib, a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other ...
FDA Accepts NDA for First Potential Treatment for Fibrodysplasia Ossificans Progressiva americanpharmaceuticalreview
June 04, 2021
Ipsen announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the ...
Zydus Cadila gets tentative US FDA nod for Osimertinib Tablets expresspharma
June 04, 2021
Zydus Cadila has received tentative approval from the USFDA to market Osimertinib Tablets in the strengths of 40 mg and 80 mg (US RLD: Tagrisso Tablets). Osimertinib is used to treat lung cancer.
CPL Completes Successful Virtual Health Canada Audit contractpharma
June 04, 2021
The CDMO created a virtual tour of its facilities in response to the pandemic.
Cosentyx approved to treat plaque psoriasis in paediatric patients pharmatimes
June 03, 2021
The US Food and Drug Administration (FDA) has approved Novartis’ interleukin-17A (IL-17A) inhibitor Cosentyx for the treatment of children and adolescents with moderate to severe plaque psoriasis.
NRx Pharmaceuticals seeks FDA EUA for Covid-19 therapy Zyesami pharmaceutical-technology
June 03, 2021
NRx Pharmaceuticals has submitted an application to the US Food and Drug Administration (FDA) seeking Emergency Use Authorization (EUA) for Zyesami (Aviptadil-acetate) for the treatment of critically ill Covid-19 patients with respiratory failure.
US FDA accepts biologics license application from Lupin for pegfilgrastim biosimilar expresspharma
June 03, 2021
Lupin announced that the US FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.

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