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FDA hands Cassiopea its first approval, for acne drug Winlevi

pharmaphorum

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company.

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LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

The Pharma Data

Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

HR 52
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Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S., LUMAKRAS received accelerated approval based on overall response rate and duration of response.

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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