You are here: Industry Insights > FDA

News List

FDA Expands Indication for PROGRAF® for Lung Transplant Recipients americanpharmaceuticalreview
July 22, 2021
Astellas Pharma Inc. announced that the U.S. FDA approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients.
FDA Approves Drug for Severe Itching in Patients Liver Disease americanpharmaceuticalreview
July 22, 2021
FDA has approved Bylvay (odevixibat), the first treatment for pruritus (moderate to severe itching) in patients aged three months and older with progressive familial intrahepatic cholestasis (PFIC), a rare progressive liver disease that typically ...
Former FDA adviser calls for wider probe into Biogen Alzheimer’s drug approval expresspharma
July 22, 2021
A federal probe of the US Food and Drug Administration’s approval of a controversial new Alzheimer’s disease drug should look into why that decision was made without clear evidence of patient benefit, a former adviser to the agency said 20th.
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

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page