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FDA expands IONS' Tryngolza label to treat severe hypertriglyceridemia

Ionis Pharmaceuticals IONS announced that the FDA has approved its wholly owned drug, Tryngolza (olezarsen), for a new ...

FDA expands Pfizer's Ibrance label for frontline maintenance in advanced breast cancer

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s PFE Ibrance (palbociclib) regimen for ...
Fierce Pharma

Ionis scores transformational FDA label expansion for Tryngolza

After 35 years engaged in the research and development of pharmaceutical products, Ionis began marketing its drugs for the ...
BioPharma Dive

Ionis, with new FDA nod, hits a ‘commercial inflection point’

Historically seen as a "platform monetization story," according to one analyst, Ionis now has a potential multibillion-dollar ...
The American Journal of Managed Care

FDA Approves Palbociclib for HR+, HER2+ Breast Cancer Maintenance

FDA clearance establishes the first CDK4/6 inhibitor indication spanning HR+ metastatic disease regardless of HER2 status, creating a new maintenance strategy for HR+/HER2+ tumors. PATINA randomized ...

AstraZeneca gets FDA label expansion for Truqap in prostate cancer

AstraZeneca (AZN) stock is in focus as the FDA approves a label expansion for its breast cancer therapy Truqap in prostate cancer. Read more here.
Healio

FDA approves labeled strength update to Twirla

The FDA approved an update to the labeled strength of Twirla, a weekly contraceptive patch, its manufacturer announced.The ...
zacks

INCY Obtains FDA Approval for Label Expansion of Ruxolitinib Cream

Incyte gained FDA approval for Opzelura to treat pediatric atopic dermatitis from age two. Approval was backed by TRuE-AD3 trial showing efficacy and consistent safety results. Opzelura sales hit $283 ...
Medscape

Dystrophic Epidermolysis Bullosa: FDA Approves Labeling Changes for Topical Gene Therapy

The FDA has approved an updated label for beremagene geperpavec-svdt (B-VEC), a topical gene therapy for dystrophic epidermolysis bullosa (DEB), which expands the indication from ages 6 months and ...
RAPS

FDA Finalizes Accelerated Approval Labeling Guidance

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway. FDA's accelerated approval program allows the ...
RAPS

FDA Releases New Accelerated Approval Labeling Guidance

A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how drugs approved through the accelerated approval pathway should be labeled. FDA's accelerated ...