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Moderna gets USFDA nod for bigger vials of COVID-19 vaccine
expresspharma
April 06, 2021
Moderna said its vaccine can now be supplied in vials containing 11 or 15 doses, and it expected to begin shipping 15-dose vials in coming weeks.
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Research identifies nine potential new COVID-19 treatments
expresspharma
April 06, 2021
Three already have FDA approval — the transplant-rejection drug cyclosporine, the cancer drug dacomitinib, and the antibiotic salinomycin.
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US FDA Approved Jemincare to Initiate Clinical Trial of Neutralizing Antibody JMB2002
prnasia
April 02, 2021
On March 31, 2021, Jemincare group announced that their anti-SARS-CoV-2 neutralizing antibody, JMB2002, independently developed by Jemincare Shanghai Research Center, was approved by FDA for clinical trial in the United States.
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Airway Announces IND Acceptance of AT-100 for Preterm Infants at Risk for BPD
americanpharmaceuticalreview
April 02, 2021
Airway Therapeutics announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to develop AT-100 (rhSP-D) as a preventive treatment for the serious respiratory disease BPD in very preterm babies.
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USFDA sends CRL to Merck’s sBLA regarding KEYTRUDA
pharmaceutical-business-review
April 02, 2021
Merck has announced that the US Food and Drug Administration (FDA) has sent a Complete Response Letter (CRL) regarding Merck’s supplemental Biologics License Application (sBLA) for the approval of KEYTRUDA.
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Aleor Dermaceuticals gets USFDA nod for Nystatin and Triamcinolone Acetonide Cream
expresspharma
April 02, 2021
Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP ...
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FDA green light for Sarclisa combo in multiple myeloma
pharmatimes
April 01, 2021
French pharma company Sanofi has received US Food and Drug Administration (FDA) approval for its CD38 inhibitor Sarclisa in combination with carfilzomib and dexamethasone (Kd) for the treatment of advanced multiple myeloma.
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Evive Biotech Submits Biologics License Application to US FDA for Ryzneuta(TM)
prnasia
March 31, 2021
Evive Biotech, a global biologics company developing novel biologic therapies, today announced the submission of its Biologics License Application (BLA) for Ryzneuta™ (also known as F-627) to the US Food & Drug Administration (FDA).
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BIOVAXYS files FDA pre-IND meeting request and briefing package for COVID-T
prnasia
March 31, 2021
BioVaxys Technology Corp., the world leader in haptenized antigen vaccines for antiviral and cancer applications, announced today that it is has filed a pre-IND (Investigational New Drug) meeting request and submitted a briefing package with the ...
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Amphastar Receives FDA Approval for Dextrose Injection
americanpharmaceuticalreview
March 30, 2021
Amphastar Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved the Company’s Abbreviated New Drug Application (ANDA) for Dextrose injection 50% in the 50 mL Luer-Jet® Prefilled Syringe System.