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Metrics Contract Services Completes Russian Regulatory Inspection contractpharma
March 10, 2021
Greenville, NC site approved to make an oncology drug to be marketed in Russia.
FDA Grants Tentative Approval to Generic Version of Symbicort contractpharma
March 10, 2021
Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
Dialectic Receives FDA Clearance for Lead Antiapoptotic Protein Targeted Degradation Candidate americanpharmaceuticalreview
March 09, 2021
Dialectic Therapeutics announced the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed with its clinical investigation for its lead product candidate, DT2216, a unique compound built using its proprietary and novel ...
FDA Accepts Dupixent for Review in Children with Moderate-to-severe Asthma americanpharmaceuticalreview
March 09, 2021
Regeneron Pharmaceuticals and Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years ...
FDA Approves Lorlatinib for Metastatic ALK-Positive NSCLC americanpharmaceuticalreview
March 09, 2021
The U.S. Food and Drug Administration (FDA) has granted regular approval to lorlatinib (Lorbrena, Pfizer) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive ...
NATCO gets US FDA nod for Everolimus tablets expresspharma
March 09, 2021
They are indicated in the treatment of breast cancer and a few other types of cancers.
KemPharm Announces FDA Approval of AZSTARYS for ADHD americanpharmaceuticalreview
March 08, 2021
KemPharm has announced the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) AZSTARYS™ (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in ...
Kite gets US FDA nod for Yescarta to treat relapsed or refractory follicular lymphoma expresspharma
March 08, 2021
Kite, a Gilead Company, announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two ...
FDA to review Sanofi’s Dupixent in children with uncontrolled asthma pharmatimes
March 05, 2021
The US Food and Drug Administration (FDA) will review Sanofi’s Dupixent as an add-on treatment for children aged six to 11 years with uncontrolled moderate-to-severe asthma.
FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A americanpharmaceuticalreview
March 05, 2021
The U.S. Food and Drug Administration (FDA) approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to Molybdenum Cofactor Deficiency Type A, a rare, genetic, metabolic disorder that typically presents in the first few days of ...

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