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Merck (MRK) Wins FDA And EMA Review For Broader RSV Use In Children
Simply Wall St.1d agobullish
Merck (MRK) Wins FDA And EMA Review For Broader RSV Use In Children

Merck (NYSE:MRK) said the FDA and EMA have accepted supplemental applications to expand ENFLONSIA for preventing RSV in young children at elevated risk. The filings seek to broaden ENFLONSIA's indication in vulnerable pediatric groups where preventative options for RSV are limited. The dual U.S. and European regulatory milestones highlight Merck's efforts to build out its portfolio beyond oncology as attention on the future of Keytruda intensifies. For investors tracking how large drug...

Moderna Earnings Are Better Than Expected So Why Is the Stock Falling?
Barrons.com12d agobullish
Moderna Earnings Are Better Than Expected So Why Is the Stock Falling?

Moderna posted a narrower per-share loss and higher revenue in its latest quarter, but shares were tumbling anyway. Moderna posted a loss of $1.97 a share, narrower than the loss of $2.01 Wall Street had anticipated, and slimmer than the per-share loss of $2.13 reported last year. The drugmaker reiterated its full-year guidance of 10% revenue growth, evenly split between U.S. and international sales.

Merck (MRK) Says KEYTRUDA Beat Chemotherapy In Phase 3 Endometrial Cancer Trial
Simply Wall St.16d agobullish
Merck (MRK) Says KEYTRUDA Beat Chemotherapy In Phase 3 Endometrial Cancer Trial

Merck (NYSE:MRK) reported that KEYTRUDA met its primary endpoint of progression free survival in the Phase 3 KEYNOTE C93 trial for advanced or recurrent endometrial cancer. The company highlighted this as the first time a PD 1 inhibitor has shown a statistically significant benefit over platinum chemotherapy in this patient population. The data are described as a high impact development for Merck's oncology portfolio, with potential implications for future regulatory filings. For investors...

Big Pharma Is Buying Growth. Novartis (NVS) Is Betting on Its Pipeline
Insider Monkey21d agobullish
Big Pharma Is Buying Growth. Novartis (NVS) Is Betting on Its Pipeline

Big Pharma is buying its way out of the patent cliff, while Novartis AG (NYSE:NVS) is trying to out-develop it. A Record Year for Biotech Deals The scale of that buying activity appears in this year’s deal totals. Biotech M&A has hit a record pace in 2026, with deal value reaching $216 billion so far […]

Merck (MRK) Wins FDA Approval For First Oral PCSK9 Cholesterol Drug
Simply Wall St.24d agobullish
Merck (MRK) Wins FDA Approval For First Oral PCSK9 Cholesterol Drug

Merck (NYSE:MRK) received FDA approval for Lipfendra (enlicitide), the first oral PCSK9 cholesterol-lowering drug. Lipfendra introduces an oral option for patients who have so far relied on injectable PCSK9 therapies. The approval expands Merck’s presence in cardiovascular medicine as key products approach patent expirations. Merck, trading around $127.5, is adding Lipfendra to its portfolio at a time when NYSE:MRK has posted a 64.8% return over the past year and 92.2% over five years. The...

Merck (MRK) Wins FDA Nod For New Keytruda Bladder Cancer Use
Simply Wall St.28d agobullish
Merck (MRK) Wins FDA Nod For New Keytruda Bladder Cancer Use

Merck (NYSE:MRK) received FDA approval for expanded use of Keytruda and Keytruda QLEX combinations with Padcev in muscle-invasive bladder cancer. The decision is based on results from the pivotal Phase 3 KEYNOTE-B15 study. This is the first PD-1 inhibitor plus antibody drug conjugate regimen cleared for these patients regardless of cisplatin eligibility. The latest approval adds another indication for Merck's flagship oncology drug Keytruda. It reinforces the company’s presence in bladder...