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Maroc Maroc - ZACKS.COM - All Stories - 27/Jun 14:21

Merck's (MRK) Lung Cancer Candidate Faces FDA Rejection

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.

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Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

drugs.com - 26/Jun 04:06

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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AbbVie (ABBV) Parkinson's Candidate Faces 2nd FDA Rejection

zacks.com - 26/Jun 13:05

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...

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Pharma Stock Roundup: FDA's CRL to MRK & ABBV, Phase III Study Failures for NVO, AZN

zacks.com - 28/Jun 13:13

FDA rejects Merck (MRK) and AbbVie's (ABBV) filings for pipeline candidates. AstraZeneca (AZN) and Novo Nordisk (NVO) announce study failures.

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Merck (MRK) Gets Exclusive Rights to Opevesostat From Partner

zacks.com - 12:43

Merck (MRK) exercises the option that will convert the collaboration deal with partner Orion for prostate cancer candidate opevesostat into a license...

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Merck (MRK) Gets Exclusive Rights to Opevesostat From Partner

zacks.com - 12:43

Merck (MRK) exercises the option that will convert the collaboration deal with partner Orion for prostate cancer candidate opevesostat into a license...

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Glioblastoma Multiforme Pipeline Insights 2024 | Clinical Trials, Latest Approvals, Treatment Outlook, Therapies, Companies | Genentech, Merck, Daiichi Sankyo, VBL Therapeutics, Diffusion Pharma

mountaintoday.in - 19/Jun 07:44

Glioblastoma Multiforme Pipeline Insights 2024 As per DelveInsight’s assessment, about 100+ key pharma and biotech companies are working on 100+...

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Merck (MRK) Gets CHMP Nod for PAH Drug Winrevair in Europe

zacks.com - 01/Jul 09:30

Merck's (MRK) Winrevair is poised to become the first activin signaling inhibitor therapy for PAH in Europe if approved by the European Commission.

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Pharma Stock Roundup: FDA Nod to MRK's New Jab & Expanded Use of ABBV & AZN Drugs

zacks.com - 21/Jun 13:45

FDA approves Merck's (MRK) 21-valent pneumococcal conjugate vaccine, Capvaxive and the expanded use of AbbVie's (ABBV) Skyrizi and AstraZeneca's (AZN)...

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FDA Rejects Rocket's (RCKT) Gene Therapy BLA for Rare Disease

zacks.com - 01/Jul 14:31

Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte...

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Merck's (MRK) New Pneumococcal Jab Capvaxive Gets CDC Panel Vote

zacks.com - 28/Jun 11:28

Merck's (MRK) vaccine, Capvaxive, gets unanimous recommendation by a CDC committee for adults aged 65 years and older for pneumococcal vaccination and...