Brand & Product Security

Articles

Zynrelef was initially approved by the FDA for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

Indication for Zynrelef Expanded to Include Orthopedic, Soft Tissue Procedures

Tesamorelin (Egrifta) was initially approved by the FDA in November 2010 for the treatment of lipodystrophy in patients also diagnosed with HIV.

sBLA for New Formulation of Tesamorelin Issued Complete Response Letter by FDA

FDA adds Boxed Warning that the osteoporosis medication increases the risk for severe hypocalcemia in patients with advanced chronic kidney disease, especially among those undergoing dialysis

FDA Warns Against Risk of Hypocalcemia in Patients With Kidney Disease Taking Prolia 

Podcasts

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA). 

Complying With the DSCSA

Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. 

FDA to Require Boxed Warning Labels on CAR T-Cell Therapies for Secondary Cancer Risks

The FDA assigned Autolus Therapeutics' biologics license application for obecabtagene autoleucel with a Prescription Drug User Fee Act date of November 16, 2024.

FDA to Evaluate BLA for Obe-Cel to Treat B-Cell Acute Lymphoblastic Leukemia 

NK010, which showed promising anti-tumor activity and safety in preclinical studies, will be evaluated in a Phase I clinical trial for ovarian cancer.

FDA Clears Trial of Non-Genetically Modified Natural Killer Cell Therapy

The addressable treatment market for osteopenia is projected to reach more than $30 billion in the United States and $100 billion globally.

Osteoboost Device Gains FDA Clearance to Treat Osteopenia in Postmenopausal Women

Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.

Balversa Gets Full FDA Approval for Locally Advanced, Metastatic Urothelial Carcinoma 

Patients with chronic inflammatory demyelinating polyneuropathy administered HyQvia showed a statistically significant difference between relapse rates compared with placebo.

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