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US FDA approves Viltepso injection for treatment of Duchenne muscular dystrophy mutation
expresspharma
August 14, 2020
The US Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
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Aleor Dermaceuticals receives USFDA tentative approval for antifungal medication
expresspharma
August 14, 2020
Tavaborole topical solution, 5% is indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
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FDA clears Appili Therapeutics to expand its trial of favipiravir for prrevention of Covid-19
pharmaceutical-business-review
August 13, 2020
Appili Therapeutics, a biopharmaceutical company focused on anti-infective drug development, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of ...
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FDA Posts Additional Postmarket Information for Essure
americanpharmaceuticalreview
August 13, 2020
On April 24, 2020, the FDA granted, in part, Bayer’s request for a variance from some medical device reporting requirements subject to the conditions outlined in a letter issued to Bayer.
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FDA Revokes EUA for Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test
americanpharmaceuticalreview
August 13, 2020
The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) of the Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Tests.
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PTC Therapeutics Announces FDA Approval of Evrysdi for Spinal Muscular Atrophy
americanpharmaceuticalreview
August 13, 2020
PTC Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved Evrysdi™ (risdiplam), the first at-home, orally administered treatment for spinal muscular atrophy (SMA) in adults and children 2 months and older.
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FDA Approves BLENREP
americanpharmaceuticalreview
August 13, 2020
The U.S. Food and Drug Administration (FDA) approved BLENREP (belantamab mafodotin-blmf) for the treatment of adult patients with relapsed or refractory multiple myeloma ...
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US FDA approves Lampit for the treatment of Chagas disease in children
pharmaceutical-business-review
August 12, 2020
Bayer announced that the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease ...
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Activity at Kodak Pharmaceuticals regarding US government loan to be reviewed
europeanpharmaceuticalreview
August 12, 2020
After “allegations of wrongdoing” were connected to Eastman Kodak Company following a $765 million loan from the US government, a review has been announced.
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FDA Grants Accelerated Approval to tafasitamab-cxix for Diffuse Large B-Cell Lymphoma
americanpharmaceuticalreview
August 12, 2020
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US).