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Cassiopea secures FDA approval for Winlevi topical acne treatment
pharmaceutical-technology
August 28, 2020
Italian speciality pharmaceutical firm Cassiopea has received approval from the US Food and Drug Administration (FDA) for Winlevi (clascoterone cream 1%) as a topical treatment for acne vulgaris.
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Dr Reddy’s Laboratories launches penicillamine capsules in US
expresspharma
August 28, 2020
It is a chelating agent used in the treatment of Wilson’s disease and to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis.
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Alembic Pharma gets tentative nod from USFDA for Empagliflozin and Linagliptin tablets
expresspharma
August 28, 2020
Empagliflozin and Linagliptin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Aleor Dermaceuticals receives USFDA nod for Desonide lotion
expresspharma
August 27, 2020
It indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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FDA's emergency nod for convalescent plasma sparks questions of whether it's bowing to Trump
fiercepharma
August 26, 2020
Hospitalized COVID-19 patients in the U.S. have another treatment option in the U.S. after the FDA’s emergency authorization for convalescent plasma on Sunday.
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FDA faces a reputation crisis amid Trump pressure for fast COVID action—and that's bad news for pharma
fiercepharma
August 26, 2020
Critics are slamming the FDA and Commissioner Stephen Hahn for authorizing COVID-19 plasma treatment prematurely, but the issue is much broader than one emergency use authorization. The agency's reputation is on the line.
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FDA chief Hahn walks back plasma claims, but his correction still missed the mark, experts say
fiercepharma
August 26, 2020
With the emergency use authorization (EUA) for convalescent plasma to treat COVID-19, the FDA and Commissioner Stephen Hahn, M.D., touched off a controversy—particularly about his presentation of the evidence and the political pressure from the White Hous
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FDA issues emergency use authorisation for COVID-19 convalescent plasma
europeanpharmaceuticalreview
August 26, 2020
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
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FDA Accepts NDA Filing for Tepotinib for Metastatic NSCLC with METex14 Skipping Alterations
americanpharmaceuticalreview
August 26, 2020
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, has announced the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) for ...
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FDA Provides Update on Pooled Sample Testing and Screening Testing for COVID-19
americanpharmaceuticalreview
August 26, 2020
The U.S. Food and Drug Administration (FDA) has taken steps to encourage the development of tests for screening asymptomatic individuals and for testing pooled samples, as summarized in the June 16, 2020 ...