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FDA Issues Guidance for Conducting COVID-19 Clinical Trials americanpharmaceuticalreview
March 19, 2020
The U.S. Food and Drug Administration (FDA) issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
Biohaven's Verdiperstat Receives Fast Track Designation for Multiple System Atrophy Treatment americanpharmaceuticalreview
March 19, 2020
Biohaven Pharmaceutical announced the Company's myeloperoxidase (MPO) inhibitor, verdiperstat, received Fast Track designation from the US Food and Drug Administration (FDA) ...
FDA approves label update to sodium glucose co-transporter-2 (SGLT2) inhibitors europeanpharmaceuticalreview
March 19, 2020
Safety updates to labels of SGLT2 inhibitors will recommend temporary discontinuation of these medications before scheduled surgery, says the FDA.
FDA Grants Accelerated Approval to Nivolumab, Ipilimumab Combination americanpharmaceuticalreview
March 18, 2020
The Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY, Bristol-Myers Squibb Co.) ...
FDA Updates Coronavirus Policy contractpharma
March 18, 2020
Policy addresses labs and commercial manufacturers to expand the number and variety of diagnostic tests to achieve more rapid testing capacity in the U.S.
Biohaven Wins FDA Approval for NURTEC ODT contractpharma
March 18, 2020
Developed in partnership with Catalent using its Zydis orally disintegrating tablet (ODT) technology.
Alembic Pharma gets EIR from US FDA for Karakhadi API facility expresspharma
March 18, 2020
Alembic Pharmaceuticals on Tuesday said it has received an EIR from the US health regulator after inspection of its active pharmaceutical ingredient (API) facility at Karakhadi in Gujarat.
FDA clears first clinical study for a polymicrobial phage library-based treatment for antibiotic-resistant infections pharmaceutical-business-review
March 17, 2020
Adaptive Phage Therapeutics (APT) said that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank.
Roche's cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization worldpharmanews
March 17, 2020
Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test.
FDA Allows New York State Department of Health Testing Authorization americanpharmaceuticalreview
March 17, 2020
The U.S. Food and Drug Administration (FDA) took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).

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