Pharma News - Chemdiv

FDA Expands Approval of Bayer’s Nubeqa for Prostate Cancer

The FDA has expanded its approval of Bayer’s cancer drug Nubeqa (darolutamide), this time approving the drug in combination with the chemotherapy drug docetaxel for adult patients with metastatic...

Newly discovered chemical reactions may explain the origin of life

Exactly how inanimate molecules came to life is one of science’s most enigmatic mysteries.

Genentech Inks Licensing Deal With Kiniksa Pharmaceuticals

Genentech has inked a licensing and development deal with Bermuda-based biotech Kiniksa Pharmaceuticals for the company’s investigational drug vixarelimab.

FDA Considers Splitting Jynneos Vaccine Into Fifths for Monkeypox

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...

FDA Declines Travere’s Second Attempt at Accelerated Approval for Sparsentan

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 to Make Bebtelovimab Commercially Available

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 Launches Its First Lower-Cost Generic Drug

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 Receives FDA Breakthrough Therapy Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

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...

VAX-24 Pneumococcal Vaccine Receives FDA Fast Track Designation

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...

FDA Issues 48 Product-Specific Guidances for Generic Drug Development

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 (oteseconazole) to Treat Recurrent Vulvovaginal Candidiasis, USA

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

Ipsen’s Onivyde Failed to Meet Primary Endpoint in SCLC Phase 3 Study

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...