Lupin launches Leflunomide Tablets USP
These tablets are indicated for the treatment of adults with active rheumatoid arthritis
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US FDA
US FDA issues warning to Mylan for Telangana plant
It has also recommended the company to engage a cGMP Consultant
US FDA releases guidance to detect and prevent nitrosamines in drugs
It recommends steps, including a comprehensive risk assessment strategy and other actions
US FDA approves Onureg (azacitidine tablets) to treat acute myeloid leukaemia
AML is one of the most common acute leukaemias in adults
INmune Bio gets US FDA nod for Phase II trial of Quellor, a sTNF inhibitor for COVID-19 treatment
Trial to evaluate the efficacy of Quellor to blunt the cytokine storm and decrease the catastrophic complications of COVID-19…
US FDA willing to give EUA for COVID-19 vaccines before Phase III trials
FDA Commissioner also said that it is not a blanket approval and will be subject to benefits outweighing the risks
US FDA broadens EUA for Veklury (remdesivir) to treat all hospitalised COVID-19 patients
The expansion is supported by the FDA’s analysis of additional data from two randomised, controlled clinical trials that included…
US FDA approves Winlevi, topical acne treatment from Cassiopea
Reportedly, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago
Dr Reddy’s Laboratories launches penicillamine capsules in US
It is a chelating agent used in the treatment of Wilson’s disease and to reduce cystine excretion in cystinuria and to treat…
Amneal gets US FDA approval for Lidocaine Patch
It is indicated for the treatment of post-herpetic neuralgia