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FDA approves Zeposia® (ozanimod) to treat relapsing forms of multiple sclerosis
europeanpharmaceuticalreview
March 31, 2020
The US FDA has granted approval to BMS for Zeposia, a once daily oral medication for the treatment of relapsing forms of multiple sclerosis.
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FDA approves AstraZeneca’s Imfinzi for small cell lung cancer
pharmaceutical-technology
March 31, 2020
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Imfinzi (durvalumab) for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in adults.
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Lupin’s Inhalation Research Center, Florida receives EIR from US FDA
expresspharma
March 31, 2020
Pharma major Lupin announced the receipt of the Establishment Inspection Report (EIR) from the US FDA for its Inhalation Research Center located at Coral Springs, Florida.
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Strides announces successful completion of US FDA inspection conducted at Bangalore facility
expresspharma
March 31, 2020
Strides Pharma Science announced that it has received the Establishment Inspection Report (EIR) for the inspection conducted by the US FDA in January 2020 at Company’s flagship facility KRS Gardens, Bangalore.
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US FDA classifies Sun Pharma’s Halol facility as official action indicated
expresspharma
March 31, 2020
Drug major Sun Pharmaceutical on Sunday said the US health regulator has classified its Halol facility in Gujarat as Official Action Indicated (OAI).
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ClinOne’s remote clinical trial patient management technology allows pharmaceutical companies to continue clinical research efforts amidst Covid-19 pandemic in accordance with FDA guidelines
pharmaceutical-business-review
March 30, 2020
The Covid-19 pandemic has shined a bright light on the need to manage patients remotely wherever possible.
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FDA Takes Action to Increase U.S. Supplies through Instructions for PPE, Device Manufacturers
americanpharmaceuticalreview
March 30, 2020
The U.S. Food and Drug Administration (FDA) took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.
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FDA Reports EpiPen Auto-Injector Errors due to Malfunctions
americanpharmaceuticalreview
March 30, 2020
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers and health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors ...
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ANI Files Prior Approval Supplement for Purified Cortrophin Gel 80 U/mL
americanpharmaceuticalreview
March 27, 2020
ANI Pharmaceuticals has submitted a prior approval supplement (PAS) to the Endocrinology Division at the FDA for re-commercialization of Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL).
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FDA Allows Patients to use VERO’s Nitric Oxide at Home
contractpharma
March 27, 2020
Genosyl DS system facilitates outpatient use of inhaled nitric oxide in the treatment of cardiopulmonary symptoms associated with COVID-19.