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Homepage > Company > Media > Pharma News > 2023

Pharma News, 2023

Many Accelerated Approval Drug Labels Lack Required Marketing Information
Many Accelerated Approval Drug Labels Lack Required Marketing Information

More than 10 percent of drugs marketed with an Accelerated Approval (AA) failed to include mention of the AA on the label, a new study has found.

FDA Accepts Ionis NDA for Eplontersen in Rare Hereditary Disease
FDA Accepts Ionis NDA for Eplontersen in Rare Hereditary Disease
The FDA has accepted Ionis Pharmaceuticals’ new drug application (NDA) for eplontersen to treat patients with hereditary transthyretin-mediated amyloid polyneuropathy, a rare inherited genetic condi...
J&J-backed Rapport Therapeutics snags $100M for precision approach to neurological diseases
J&J-backed Rapport Therapeutics snags $100M for precision approach to neurological diseases
Rapport Therapeutics, a clinical-stage biotech aiming to develop precision medicines for neurological disorders, launched Tuesday with $100 million in Series A financing from Third Rock Ventures, A...
FDA Expands Approval of Eli Lilly’s Verzenio for High-Risk Early Breast Cancer
FDA Expands Approval of Eli Lilly’s Verzenio for High-Risk Early Breast Cancer
The FDA has granted expanded approval to Eli Lilly’s Verzenio (abemaciclib) with endocrine therapy (tamoxifen or an aromatase inhibitor) as adjuvant treatment in adult patients with hormone rece...
FDA Approves IM Administration of Merck’s MMRV Family of Vaccines
FDA Approves IM Administration of Merck’s MMRV Family of Vaccines
The FDA approved the inclusion of intramuscular (IM) administration to the U.S. package insert for Merck’s measles-mumps-rubella-varicella (MMRV) family of vaccines, increasing the options for ad...
Merck’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study
Merck’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study
Merck, known as MSD outside of the United States and Canada, today announced results from the Phase 2b clinical trial evaluating MK-0616, an investigational, once-daily oral proprotein convertase s...
FDA Denies Petition to Grant Simufilam Breakthrough Designation
FDA Denies Petition to Grant Simufilam Breakthrough Designation
The FDA has denied a citizen petition to grant a breakthrough therapy designation for Cassava Science’s investigational Alzheimer’s therapy, simufilam, because the petition was submitted by an ind...
Ractigen’s ALS Drug Candidate Gains Orphan Drug Designation
Ractigen’s ALS Drug Candidate Gains Orphan Drug Designation
The FDA has granted Orphan Drug status to Ractigen Therapeutics’ RAG-17, an investigational treatment of patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ...
AstraZeneca says cancer drug Enhertu showed positive results
AstraZeneca says cancer drug Enhertu showed positive results
AstraZeneca PLC on Monday said its cancer drug Enhertu has shown clinically meaningful and durable responses across multiple HER2-expressing advanced solid tumors in its DESTINY-PanTumor02 Phase II...
FDA will review Eisai and Biogen’s Alzheimer’s treatment Leqembi with decision on full approval expected in early July
FDA will review Eisai and Biogen’s Alzheimer’s treatment Leqembi with decision on full approval expected in early July

FDA will review Eisai and Biogen’s Alzheimer’s treatment Leqembi with decision on full approval expected in early July.

Future of generative AI in pharma
Future of generative AI in pharma
Across all industries, generative AI has become the latest buzz word. Talk of implementing automation and AI solutions to enhance human capacity continues to dominate conversations. In fact, ventur...
Exelixis Provides Update on Phase 3 CONTACT-03 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Previously Treated Advanced Kidney Cancer
Exelixis Provides Update on Phase 3 CONTACT-03 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Previously Treated Advanced Kidney Cancer

Exelixis, Inc. today announced that the phase 3 CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS).

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