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FDA approves Janssen’s Rybrevant pharmatimes
May 25, 2021
The US Food and Drug Administration (FDA) has approved Janssen’s Rybrevant as the first treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Glenmark gets US FDA nod for Icatibant injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe expresspharma
May 25, 2021
This marks Glenmark’s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.
FDA Approves Nivolumab for Resected Esophageal or GEJ Cancer americanpharmaceuticalreview
May 24, 2021
On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received ...
U.S. Food & Drug Administration Grants Priority Review of Maribavir americanpharmaceuticalreview
May 24, 2021
Takeda Pharmaceutical Company Limited announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir for the treatment of CMV infection in those that are refractory with or without resistance (R/R) ...
Natco Pharma gets USFDA approval for lenalidomide capsules expresspharma
May 24, 2021
Natco Pharma has received final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 5 mg, 10 mg, 15 mg, and 25 mg strengths, from the US Food and Drug Administration (FDA), and tentative approval for the 2.5 mg and 20 mg ...
FDA Receives Health and Human Services Grant to Expand Cure ID Platform for COVID-19 Treatments americanpharmaceuticalreview
May 21, 2021
FDA’s Clinical Methodologies Group (ClinMeth) received a $9.2 million grant through the HHS Office of the Assistant Secretary for Planning and Evaluation’s (ASPE) Patient-Centered Outcomes Research Trust Fund.
FDA Publishes Product-Specific Guidelines for Generic Drug Development americanpharmaceuticalreview
May 21, 2021
The FDA published a new batch of product-specific guidelines (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval.
Unichem Labs gets US FDA approval for Amitriptyline HCL Tablets expresspharma
May 21, 2021
Unichem Laboratories has received ANDA approval for its Amitriptyline HCL Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the United States Food and Drug Administration (USFDA) to market a generic version of ELAVIL ...
FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available firstwordpharma
May 21, 2021
Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end. Pfizer Inc. submitted data to the FDA to support storage of undiluted
Kintor Announced (1) FDA Has Greenlighted Proxalutamide's Phase III Study for Hospitalized Male and Female COVID-19 Patients to Be Conducted; and (2) Inclusion of Female Outpatients in Proxalutamide's prnasia
May 20, 2021
On May 18, Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the U.S. Food and Drug Administration (FDA) has greenlighted proxalutamide's phase III ...

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