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GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

The Pharma Data

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [i]

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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., For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies.

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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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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated.

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Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. endocrinopathies and dermatologic reactions) are discussed below.

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Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

The Pharma Data

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. endocrinopathies and dermatologic reactions) are discussed below.

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CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Institute hormone replacement therapy for endocrinopathies as warranted.

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