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FDA grants BTD for Venclexta in combination with azacitidine to treat patients with myelodysplastic syndromes expresspharma
July 22, 2021
Every year, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS) in the US, and there remains a high unmet need for new treatment options.
Organicell Announces FDA Approval Of IND Application For The Use Of Zofin™ In COVID-19 Long Haulers prnewswire
July 22, 2021
announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, for the treatment of 'Prolonged COVID-19 Symptoms' ("Long Haulers").
FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) drugs
July 21, 2021
Albireo Pharma, Inc. today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC).
ADMA Biologics Completes FDA Manufacturing Facility Inspection americanpharmaceuticalreview
July 21, 2021
ADMA Biologics Inc. announced the US FDA completed its Pre-Approval Inspection (“PAI”) of the Boca Raton, FL manufacturing facility related to ADMA's application for its VanRx SA25 Workcell aseptic fill-finish machine (“VanRx”).
FDA Update on Chantix with Nitrosamine Impurity americanpharmaceuticalreview
July 20, 2021
To ensure patient access to Chantix (varenicline), the FDA will not object to certain manufacturers temporarily distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the ...
FDA Approves Belumosudil for Graft-Versus-Host Disease americanpharmaceuticalreview
July 20, 2021
The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including ...
FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults drugs
July 20, 2021
(NYSE: MRK) today announced the FDA approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease drugs
July 20, 2021
FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic kidney disease (CKD) in NDD adult patients.
Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film drugs
July 20, 2021
Aquestive Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters.
FDA Approves Fexinidazole as the First All-Oral Treatment for Sleeping Sickness drugs
July 20, 2021
The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness in patients 6 years of age and older and weighing at least 20 kg.

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