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The approval of Ogsiveo represents an important therapeutic advance for patients with progressing desmoid tumors requiring systemic treatment.

Ogsiveo Approved by FDA for Progressing Desmoid Tumors 

AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly) for the treatment of adults with follicular lymphoma that is relapsed or refractory following treatment with two or more therapies.

FDA Grants Breakthrough Therapy Designation to Bispecific Antibody for Follicular Lymphoma 

Alladapt Immunotherapeutics said the FDA Fast Track designation highlights the importance of developing a treatment for multiple food allergens.

Novel Multi-Food Allergy Immunotherapy Fast Tracked by FDA

Webinar Date/Time: Thu, Dec 14, 2023 11:00 AM EST

Is Your Serialization Program Complete and Sustainable?

The FDA also approved a companion diagnostic test to detect the PIK3CA, AKT1, and PTEN alterations as part of the approval for AstraZeneca’s capivasertib (Truqap) plus fulvestrant (Faslodex) for HR-positive, HER2-negative locally advanced or metastatic breast cancer.

Truqap Combination Approved by FDA for HR-Positive, HER2-Negative Locally Advanced, Metastatic Breast Cancer

Enzalutamide (Xtandi) gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

FDA Approves New Drug Application for Xtandi in nmCSPC With High-Risk Biochemical Recurrence

With new mandates right around the corner, there is an unwavering demand for pharma operations to perform at peak efficiency.

The Power of Centralized Distribution in the Face of DSCSA Compliance

Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer approved by FDA after being found to lower the risk of metastasis or death.

FDA Approves Merck's Keytruda With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Bristol Myers Squibb’s repotrectinib (Augtyro) approved by FDA to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.

FDA Approves New Treatment for ROS1-Positive Non-Small Cell Lung Cancer 

Patients with kidney failure administered chronic hemodialysis who received DefenCath showed a statistically significant lower incidence of catheter-related bloodstream infections.

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