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

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

zacks.com - 27/Jun 14:21

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...

AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)

drugs.com - 25/Jun 21:06

NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food...

Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of Krazati (adagrasib) in Combination with Cetuximab for Adult Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)

drugs.com - 21/Jun 20:06

PRINCETON, N.J.--(BUSINESS WIRE) June 21, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA)...

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...

IceCure Medical (ICCM) New Cryoablation System Gets FDA Nod

zacks.com - 15:50

IceCure Medical's (ICCM) XSense Cryoablation System receives FDA approval, marking a pivotal step in minimally-invasive tumor treatment across...

FDA Converts Tuberculosis Treatment Sirturo to Traditional Approval

drugs.com - 21/Jun 23:06

On June 21, 2024, the FDA converted Sirturo (bedaquiline) from accelerated approval to traditional approval following a determination that a...

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...

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma

oncologynews.com.au - 01/Jul 16:26

On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager,...

MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

healthtechzone.com - 26/Jun 13:15

Harmony Biosciences Receives U.S. Food And Drug Administration Approval for Wakix (pitolisant) In Pediatric Patients With Narcolepsy

drugs.com - 24/Jun 23:06

PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration...

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