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FDA Approves Label Changes to Hydrochlorothiazide
americanpharmaceuticalreview
August 24, 2020
The U.S. Food and Drug Administration (FDA) has approved changes to the hydrochlorothiazide (HCTZ) drug label to inform health care professionals and patients about a small increased risk of non-melanoma skin cancer (basal cell skin cancer or squamous ...
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US FDA approves Novartis Kesimpta (ofatumumab) for relapsing forms of MS treatment
expresspharma
August 24, 2020
Ofatumumab was first approved by the FDA in 2009 for the treatment of chronic lymphocytic leukaemia (CLL).
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Strides gets USFDA approval for Ursodiol tablets
expresspharma
August 24, 2020
Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Ursodiol tablets USP, 250 mg and 500 mg from the United States Food & Drug Administration (USFDA).
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Lupin recalls around 5.61 lakh pouches of Mibelas 24 Fe in the US
expresspharma
August 24, 2020
The product, manufactured in India and then supplied in the US market by Lupin Pharmaceuticals, is used to prevent pregnancy.
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US pharma firm, Advanced Penetration Technology tests FDA-approved ointment to treat COVID-19
expresspharma
August 24, 2020
A research concludes that APT T3X effectively neutralises viral infectivity within seconds and its topical intranasal use can decrease the viral load of exposure.
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Granules Pharma receives US FDA approval for Ramelteon tablets
expresspharma
August 24, 2020
The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India for Ramelteon tablets, 8 mg.
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FDA releases guidance on bioavailability and bioequivalence study samples
europeanpharmaceuticalreview
August 21, 2020
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
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FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord
americanpharmaceuticalreview
August 21, 2020
The U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive.
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Imfinzi Granted FDA Priority Review for Less-Frequent, Fixed-Dose Use
americanpharmaceuticalreview
August 21, 2020
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications ...
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FDA Accepts sNDA for Tyvaso from United Therapeutics
americanpharmaceuticalreview
August 21, 2020
United Therapeutics announced the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with ...