-
FDA Approves Additional Doses of Trulicity for Type 2 Diabetes
americanpharmaceuticalreview
September 07, 2020
The U.S. Food and Drug Administration (FDA) has approved two additional doses of Eli Lilly and Company's Trulicity® (dulaglutide).
-
Roche’s Genentech gets US FDA approval for Gavreto (pralsetinib)
expresspharma
September 07, 2020
The drug is used to treat metastatic RET fusion-positive non-small cell lung cancer.
-
Lilly gets US FDA nod for additional doses of Trulicity (dulaglutide) to treat type 2 diabetes
expresspharma
September 07, 2020
The US Food and Drug Administration (FDA) approved two additional doses of Eli Lilly and Company’s Trulicity (dulaglutide). The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11.
-
Dr Reddy’s Labs launch methylphenidate hydrochloride extended-release tablets USP in US
expresspharma
September 04, 2020
It is indicated for treatment of ADHD in children six years of age and older, adolescents, and adults up to the age of 65.
-
Zydus Cadila gets USFDA nod to market midodrine hydrochloride tablets
expresspharma
September 04, 2020
These tablets are indicated to treat patients who have symptoms of low blood pressure when standing, a condition known as orthostatic hypotension.
-
USFDA approves prednisone tablets from Strides Pharma
expresspharma
September 04, 2020
Prednisone is a corticosteroid used in treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.
-
Omeros’ investigational new drug application for OMS906 cleared by FDA
pharmaceutical-business-review
September 03, 2020
Omeros Corporation today announced that its Investigational New Drug Application (IND) to begin clinical trials with OMS906 has been cleared by the U.S. Food and Drug Administration (FDA).
-
US FDA approves Onureg (azacitidine tablets) to treat acute myeloid leukaemia
expresspharma
September 03, 2020
Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukaemia (AML) ...
-
Zydus Cadila gets US FDA approval for Cisatracurium Besylate Injection
expresspharma
September 03, 2020
Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex) in the strength of 20 mg (base)/10 mL (2 mg/mL) multiple-dose vial.
-
US FDA releases guidance to detect and prevent nitrosamines in drugs
expresspharma
September 03, 2020
The US Food and Drug Administration (US FDA) has published guidance ‘Control of Nitrosamine Impurities in Human Drugs’ for immediate implementation.