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FDA updates Covid-19 variant guidance for vaccines and therapies pharmaceutical-technology
February 25, 2021
US healthcare regulator the Food and Drug Administration (FDA) has updated its guidance to help vaccine and therapeutics companies to address the emergence of new variants of SARS-CoV-2, the virus that causes Covid-19.
Glenmark gets USFDA approval for Clindamycin Phosphate Gel expresspharma
February 25, 2021
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Clindamycin Phosphate Gel USP, 1%, the generic version of Cleocin T Gel, 1%, of Pharmacia & Upjohn.
Strides gets USFDA nod for Ibuprofen OTC Oral Suspension expresspharma
February 25, 2021
Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) from the United States Food & Drug Administration (USFDA).
Granules India gets USFDA approval for OTC Acetaminophen, Aspirin and Caffeine Tablets expresspharma
February 25, 2021
Granules India announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).
FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics europeanpharmaceuticalreview
February 24, 2021
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
FDA Authorizes Everlywell's COVID-19 Test Home Collection Kit americanpharmaceuticalreview
February 24, 2021
Everlywell announced the Everlywell COVID-19 Test Home Collection Kit DTC is now available for broad use without a prescription, including purchase by asymptomatic individuals, retailers, pharmacies, and organizations.
Astellas, Seagen Submit sBLAs for PADCEV for Urothelial Cancer americanpharmaceuticalreview
February 24, 2021
Astellas Pharma and Seagen announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV® (enfortumab vedotin-ejfv).
Pfizer, BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature americanpharmaceuticalreview
February 24, 2021
Pfizer and BioNTech announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in ...
USFDA denies application from SPARC for cancer drug expresspharma
February 24, 2021
The Office of New Drugs of the US FDA requested the conduct of a new Phase 3 study in metastatic breast cancer patients to support any potential resubmission of the Taclantis NDA.
US FDA says trials of modified vaccines for COVID-19 variants could take months expresspharma
February 24, 2021
Acting FDA Commissioner Janet Woodcock said companies should not wait until a mutated virus is demonstrated to be able to escape the vaccines to begin developing new versions.

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