Alembic Pharma gets VAI classification from USFDA for Panelav facility
The US FDA inspection was conducted from March 9-13, 2020
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US FDA
US FDA gives EUA to Roche for COVID-19 antibody test
The company aims to more than double production of tests from about 50 million a month to significantly more than 100 million a…
US FDA issues EUA for remdesivir for COVID-19 treatment
The EUA allows for remdesivir to be distributed in the US and administered intravenously by healthcare providers, as appropriate,…
Wockhardt’s QIDP status for WCK 6777 reflects unmet need and untapped market opportunity:…
WCK 6777 targets multidrug resistance bacterial infections where unmet need is high, translating to an untapped market…
Lupin’s Pithampur Unit-1 facility receives EIR from US FDA
The inspection for the facility was conducted by the US FDA between February 3, 2020 and February 11, 2020 and concluded with two…
Lupin Receives Tentative Approval for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL
Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL, Unit-dose Vials are indicated for the long-term maintenance…
Dr Reddy’s launches generic lipid-regulating tablets in US
The product is a generic version of AbbVie Inc's Tricor tablets
Granules India gets US FDA nod for overactive bladder treatment capsule
The product is generic version of Allergan Inc's Sanctura XR capsules in the same strength, it added
Getting Smart with Femtech: Take Advantage of this Market Potential
Siddharth Shah, Program Manager, Transformational Health, Frost & Sullivan writes about several initiatives that the…
FDA approves new therapy for triple negative breast cancer that has spread, not responded to other…
The FDA granted approval of Trodelvy to Immunomedics