The FDA's CRL to Merck (MRK) and its partner Daiichi Sankyo for the patritumab deruxtecan BLA is based on observations made on inspection of a third-party manufacturing facility.
The U.S. Food and Drug Administration declined to approve Merck and Japan-based Daiichi Sankyo's lung cancer treatment, which belongs to a lucrative class of cancer therapies that work like "guided missiles".
China's National Drug Administration has granted Merck's KEYTRUDA therapy a licence for first-line treatment of certain stomach cancer patients in the country.
Merck & Co's Frankfurt-listed shares fell 10% on Tuesday morning after the pharmaceutical giant said it had decided to call off a Phase III trial of its cancer drug Xevinapant, in an unexpected turn that threatens to undermine confidence in the company's research abilities.
Merck (MRK) closed the most recent trading day at $132.96, moving +1.71% from the previous trading session.
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Merck (MRK) closed at $127.99 in the latest trading session, marking a +0.38% move from the prior day.
The U.S. Food and Drug Administration (FDA) approved Merck & Co Inc's (NYSE:MRK) next-generation vaccine to protect adults against the pneumococcal disease.
Merck's (MRK) 21-valent pneumococcal conjugate vaccine, Capvaxive/V116, becomes the first PCV specifically designed for adults to be approved by the FDA.
Merck said on Monday the U.S. Food and Drug Administration has approved its next-generation vaccine to protect adults against pneumococcal disease.
The Food and Drug Administration approved Merck's vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia. An advisory panel to the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible for the shot, called Capvaxive
In the closing of the recent trading day, Merck (MRK) stood at $130.20, denoting a -1.24% change from the preceding trading day.