You are here: Industry Insights > FDA

News List

Radius Health Announces Acquisition of Orphan Disease Program americanpharmaceuticalreview
January 14, 2021
Radius Health announced a definitive agreement to acquire the global development and commercialization rights to Benuvia Therapeutics (Benuvia) synthetic cannabidiol oral solution (RAD011).
FDA accepts priority review of Merck’s pneumococcal vaccine pharmaceutical-technology
January 14, 2021
The US Food and Drug Administration (FDA) has accepted priority review of the Biologics License Application (BLA) of Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate, V114, for preventing invasive pneumococcal disease in adults.
Granules India gets USFDA approval of Metformin Hydrochloride ER Tablets expresspharma
January 14, 2021
Metformin Hydrochloride ER Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Inversago Pharma receives rare paediatric disease designation from FDA for INV-101 to treat Prader-Willi Syndrome pharmaceutical-business-review
January 13, 2021
Inversago Pharma, the peripheral CB1 blockade company, announced the U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease (RPD) designation to the Company’s lead compound, INV-101, for the treatment of Prader-Willi syndrome (PWS).
FDA GRANTS ADVAITE EMERGENCY USE AUTHORIZATION FOR RapCov™ Rapid COVID-19 Test prnewswire
January 13, 2021
The U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by ADVAITE Inc., an innovative biotech company developing novel point-of-care assays to help with ...
Ortho's VITROS® SARS-CoV-2 Antigen Test for Accurate, Mass-Scale COVID-19 Testing is the First High-Volume Test to Receive FDA Emergency Use Authorization prnewswire
January 13, 2021
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that its VITROS® SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive ...
FDA Grants Advaite Emergency Use Authorization FOR RapCov Rapid COVID-19 Test americanpharmaceuticalreview
January 13, 2021
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by ADVAITE.
FDA approves Phase III trial of synthetic biological COVID-19 treatment europeanpharmaceuticalreview
January 12, 2021
The international Phase III trial will evaluate whether a 14 day course of carrimycin can improve outcomes for COVID-19 patients with severe symptoms.
Bioniz Announces Positive FDA Meeting for Refractory Cutaneous T-Cell Lymphoma Treatment americanpharmaceuticalreview
January 12, 2021
Bioniz Therapeutics announced the U.S. Food and Drug Administration (FDA) provided positive feedback during the company's end of Phase 2 (EOP2) meeting for Bioniz's BNZ-1.
FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation americanpharmaceuticalreview
January 12, 2021
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 ...

Previous page 1 2 3 4 5 6 7 8 9 10 ... 367 368 Next page