Pharma News, 2022

The FDA is looking into possibly splitting doses of Bavarian Nordic’s Jynneos vaccine into fifths to inoculate individuals 18 years and older against monkeypox in order to address inadequate supp...

The FDA has rejected Travere Therapeutics’ application for accelerated approval of its investigational drug sparsentan for treatment of patients with focal segmental glomerulosclerosis, a rare d...

Eli Lilly said it will make its COVID-19 drug bebtelovimab commercially available to U.S. states and territories, hospitals and other providers later this month. ...

Civica, a nonprofit created by hospital groups to help lower generic drug prices, has launched its first product, abiraterone acetate, a prostate cancer treatment. ...

AnHeart Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational ROS-1 inhibitor taletrectinib for th...

California-based Vaxcyte, Inc. today announced that the U.S. FDA granted Fast Track designation to VAX-24, the Company’s 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prev...

The FDA has issued 29 new draft and 19 revised draft product-specific guidances meant to foster generic drug development and Abbreviated New Drug Application (ANDA) approvals. ...

VIVJOA is the first and only FDA-approved drug for the treatment of recurrent vulvovaginal candidiasis (RVVC) in females.

Ipsen’s Onivyde (irinotecan liposomal injection) failed to meet the primary endpoint of overall survival in phase 3 study investigating the drug in participants with small cell lung cancer (SCLC...

The European Commission has inked a procurement deal with Spain-based biotech company HIPRA for up to 250 million doses of its COVID-19 vaccine of behalf of EU members states. ...

Axcella Therapeutics’s investigational drug AXA1125 showed promising results in a phase 2a study involving fatigue that persists long after COVID-19 infections. ...

The FDA has approved Arcutis Biotherapeutics’ Zoryve (roflumilast) cream 0.3 percent for treatment of patients 12 years and older with plaque psoriasis and in intertriginous psoriasis — a type...