-
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 ...
-
JB Chemicals gets ANDA approval from US FDA for Loratadine Tablets
expresspharma
January 12, 2021
The tablets are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for OTC use.
-
Provention Bio Announces Teplizumab BLA for Delay or Prevention of Clinical T1D
americanpharmaceuticalreview
January 11, 2021
Provention Bio announced the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA).