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Rare Disease Therapeutics, Inc. Announces New Expanded FDA Approved Indication for Antivenom ANAVIP® for Treatment of North American Pit Viper Envenomation americanpharmaceuticalreview
April 07, 2021
Rare Disease Therapeutics, Inc. (RDT) announced that the United States (US) Food & Drug Administration (FDA) approved a new expanded indication for ANAVIP® (crotalidae immune F(ab’)2 (equine)), an equine-derived antivenin, for the management of adult ...
Exelixis Announces U.S. FDA Accepts Investigational New Drug Application for XB002 in Patients with Advanced Solid Tumors americanpharmaceuticalreview
April 07, 2021
Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with ...
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.
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.
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.
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.
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.
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 ...
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.
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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