BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...
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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.
BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...
AbbVie (ABBV) issues the second CRL for Parkinson's disease medicine, ABBV-951, based on some observations on inspection of one of its third-party...
FDA rejects Merck (MRK) and AbbVie's (ABBV) filings for pipeline candidates. AstraZeneca (AZN) and Novo Nordisk (NVO) announce study failures.
Merck (MRK) exercises the option that will convert the collaboration deal with partner Orion for prostate cancer candidate opevesostat into a license...
Merck (MRK) exercises the option that will convert the collaboration deal with partner Orion for prostate cancer candidate opevesostat into a license...
Glioblastoma Multiforme Pipeline Insights 2024 As per DelveInsight’s assessment, about 100+ key pharma and biotech companies are working on 100+...
Merck's (MRK) Winrevair is poised to become the first activin signaling inhibitor therapy for PAH in Europe if approved by the European Commission.
FDA approves Merck's (MRK) 21-valent pneumococcal conjugate vaccine, Capvaxive and the expanded use of AbbVie's (ABBV) Skyrizi and AstraZeneca's (AZN)...
Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte...
Merck's (MRK) vaccine, Capvaxive, gets unanimous recommendation by a CDC committee for adults aged 65 years and older for pneumococcal vaccination and...