Janssen
FDA Grants New Indication for Cabenuva for Every-8–Week Dosing
The FDA extended the time between shots of Cabenuva to every two months to treat HIV-1 infection in virologically ...
FEBRUARY 1, 2022

FDA Advisory Committee Votes on J&J COVID-19 Vaccine Booster Request
The company asks for an unusual caveat: The need for a booster would depend on the local/epidemiological situations ...
OCTOBER 15, 2021

FDA Okays Stelara for UC
The FDA has approved the use of ustekinumab (Stelara, Janssen) for the treatment of moderate to severe ulcerative ...
OCTOBER 21, 2019

Ibrutinib Bests Drug Combo in Older CLL Pts
In older patients with newly diagnosed chronic lymphocytic leukemia (CLL), ibrutinib provided a significant ...
MARCH 11, 2019

Single-Tablet Combo as Effective as Current HIV Treatment
If approved in the U.S., D/C/F/TAF would be the only complete regimen that could deliver the potential adherence ...
OCTOBER 11, 2017

FDA Rejects Sirukumab for RA, Requests More Data
In its complete response letter for sirukumab, the FDA said additional clinical data are needed to evaluate the ...
SEPTEMBER 27, 2017

Once-Daily, Single-Tablet Regimen Suppressed HIV
AIDS Society Conference on HIV: A once-daily, single-tablet regimen (STR) containing Prezista, Tybost, Emtriva and ...
AUGUST 1, 2017

Invokana Reduces Risk for Death From CVD
Canagliflozin significantly reduced the combined risk for death from cardiovascular disease, myocardial ...
JUNE 13, 2017
FDA Issues Warning Regarding Risk for Amputations With Diabetes Drug
The FDA issued a boxed warning for canagliflozin because it can increase the risk for leg and foot amputations.
MAY 23, 2017

2-Drug Combination Effective in Maintaining Viral Suppression in HIV Patients
The requirement of lifelong treatment for HIV infection has highlighted a need to minimize cumulative drug ...
FEBRUARY 17, 2017

FDA Grants New Indication for Imbruvica for Marginal Zone Lymphoma
Prior to this indication, there were no FDA-approved therapies specifically for this disease.
JANUARY 19, 2017

FDA Gives New Indication for Darzalex With 2 Standard Treatments for MM
Daratumumab induces tumor cell death through multiple immune-mediated mechanisms of action, including ...
NOVEMBER 22, 2016
