You are here: Industry Insights > FDA

News List

The FDA is facilitating access to convalescent plasma collected from recovered COVID-19 patients worldpharmanews
March 26, 2020
The FDA is facilitating access to convalescent plasma, antibody-rich blood products that are taken from blood donated by people who have recovered from the COVID-19 virus.
Biohaven to Advance Vazegepant into Phase 3 for Acute Treatment of Migraine americanpharmaceuticalreview
March 26, 2020
Biohaven Pharmaceutical announced a successful end of Phase 2 clinical and nonclinical interaction with the U.S. Food and Drug Administration (FDA) for intranasal vazegepant ...
FDA hands Boehringer and Lilly complete response letter for insulin adjunct March 26, 2020
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
Indian drug manufacturing facility issued FDA warning letter europeanpharmaceuticalreview
March 26, 2020
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing prnasia
March 25, 2020
PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company's New Coronavirus RT-PCR test.
FDA approves COVACTA trial for RA drug Actemra in COVID-19 patients pharmaceutical-business-review
March 25, 2020
Genentech has secured approval in the US to go ahead with the COVACTA trial to assess the use of its rheumatoid arthritis drug (RA drug) Actemra (tocilizumab) in COVID-19 patients.
FDA Alerts Consumers to Unauthorized Fraudulent COVID-19 Test Kits americanpharmaceuticalreview
March 25, 2020
The U.S. Food and Drug Administration (FDA) is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic ...
Samsung Bioepis Announces FDA Approval of 420 mg Multi-dose Vial of ONTRUZANT americanpharmaceuticalreview
March 25, 2020
Samsung Bioepis announced the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT® (trastuzumab-dttb).
FDA transitions to new regulatory pathway for biosimilars europeanpharmaceuticalreview
March 25, 2020
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
Genentech secures FDA approval to trial Actemra for Covid-19 pharmaceutical-technology
March 25, 2020
Roche unit Genentech has received US Food and Drug Administration (FDA) approval to conduct a Phase III clinical trial of its rheumatoid arthritis drug Actemra (tocilizumab) ...

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