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Sep 22, 2025 4:00 PM

FDA Clears Merck's One-Minute Cancer Shot

The U.S. Food and Drug Administration (FDA) on Friday approved Merck & Co. Inc.’s (NYSE:MRK) Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda.

Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc.

Merck expects to have Keytruda Qlex available in the U.S. in late September.

Also Read: Merck’s Exit Highlights UK Risks Losing Pharma Investment Amid Rising Costs

The pivotal trial comparing subcutaneous Keytruda Qlex to IV Keytruda administered every six ...