You are here: Industry Insights > FDA

News List

Lilly's Donanemab receives U.S. FDA's Breakthrough Therapy Designation for Treatment of Alzheimer's disease drugs
June 29, 2021
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company's (NYSE: LLY) investigational antibody therapy for Alzheimer's disease (AD).
Glenmark gets USFDA nod for generic lung cancer drug expresspharma
June 28, 2021
Glenmark Pharmaceuticals yesterday said it has received approval from the US health regulator to market Nintedanib capsules, used in the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer, in the American market.
FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis drugs
June 28, 2021
Santen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Verkazia (cyclosporine ophthalmic emulsion) 0.1% eye drops for the treatment of vernal keratoconjunctivitis (VKC) in children and adults.
Lilly to Seek FDA Approval for New Drug for Alzheimer Disease drugs
June 28, 2021
Fresh on the heels of the U.S. Food and Drug Administration approval of the controversial Alzheimer disease drug Aduhelm, the maker of a second medicine that works in similar fashion said Thursday it hopes to apply for approval of its medication later .
Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19 fda.gov
June 28, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older)
FDA issues Emergency Use Authorization for Oral CovAb™ SARS-CoV-2 Ab Test americanpharmaceuticalreview
June 25, 2021
Diabetomics, Inc., announced the granting of an Emergency Use Authorization (EUA) by the US FDA for the Company's CovAb™ SARS-CoV-2 Ab point-of-care test. The product had also received a CE mark for marketing in the EU earlier.
FDA grants breakthrough status to Eisai and Biogen’s Alzheimer’s drug pharmaceutical-technology
June 25, 2021
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eisai and Biogen’s lecanemab (BAN2401) for Alzheimer’s disease (AD) treatment.
Zydus Cadila receives tentative approval from USFDA for Pemetrexed for Injection expresspharma
June 25, 2021
Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.
Cipla gets USFDA nod for inhalation product expresspharma
June 25, 2021
The approved product is a generic version of Sunovion Pharmaceuticals Inc's Brovana.
Zydus Cadila receives tentative approval from USFDA for Fingolimod Capsules .25mg expresspharma
June 25, 2021
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

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