Yahoo Finance

Theratechnologies Submits sBLA for Trogarzo® Intramuscular (IM) Method of Administration to FDA

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, ...
Monthly Prescribing Reference

MS Therapy Plegridy Approved for Intramuscular Administration

The approval for IM use was based on data from an open-label, crossover study that assessed the bioequivalence of single doses of 125mcg of Plegridy administered as an SC and IM injection. The Food ...
Medscape

FDA Okays IM Administration for Peginterferon Beta-1a in MS

The US Food and Drug Administration (FDA) has approved intramuscular (IM) administration of peginterferon β-1a (Plegridy, Biogen) for patients with relapsing forms of multiple sclerosis (MS). "The new ...
Seeking Alpha

Theratechnologies says Trogarzo IM method of administration study did not meet primary endpoint

Biopharma Theratechnologies (NASDAQ:THTX) Friday announced that a study evaluating an intramuscular (IM) method of administration for its therapy, Trogarzo, did not meet the primary endpoint. "The ...
Pharm Exec

FDA Issues Refusal to File Letter to Theratechnologies for sBLA Seeking Approval of Intramuscular Administration of Trogarzo

Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing ...
Monthly Prescribing Reference

Intramuscular Administration of HIV Treatment Ibalizumab Compared With IV Infusion

Results were announced from a phase 3 study evaluating an investigational intramuscular (IM) formulation of ibalizumab-uiyk for the treatment of heavily treatment-experienced adults with ...
PMLiVE

New intramuscular administration for Biogen’s MS therapy Plegridy approved in the EU

The European Commission (EC) has approved a new intramuscular (IM) injection route of administration for Biogen’s Plegridy for the treatment of relapsing-remitting multiple sclerosis (RRMS). Plegridy ...