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Approvals, Launches, and New Indications

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Agent is now approved for the maintenance treatment of recurrent disease regardless of BRCA status
Approval streamlines review pathway for similar devices
First approved agent for patients who are in remission but have minimal residual disease
New pen can potentially reduce the number of injections and lower copay costs
How will it impact the competition?
Option approved to treat all forms of diabetic retinopathy in people with or without diabetic macular edema
First FDA-approved regimen in frontline stage III or IV classical Hodgkin’s lymphoma in more than 40 years
Initial 2007 approval allowed use of the drug only in adult patients
Injectable Trogarzo targets multidrug-resistant disease
St. Jude Medical valve aids in treatment of birth defects
A negative result in the 23andMe test doesn’t rule out increased cancer risk
Drug is first FDA-approved PD-1 inhibitor to offer every-four-week dosing
Lidocaine topical system offers better adhesion, company says
Used with an aromatase inhibitor, it substantially reduced tumor size and delayed disease progression
KemPharm touts benzhydrocodone/acetaminophen combo’s “unique properties”
Tablets are also indicated to treat drug-induced extrapyramidal reactions
First treatment for patients with inoperable tumors after chemoradiation
Novel clinical trial endpoint, metastasis-free survival, was used in evaluation
Quick testing option may help reduce CT scans, radiation exposure