Fierce Biotech

FDA names nine first recipients of 1-to-2 month priority review vouchers

The FDA has handed out the first nine national priority vouchers, positioning companies including Merck KGaA, Regeneron and ...
GlobalData on MSN

FDA approves Regeneron’s Libtayo for high-risk CSCC post-surgery

The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ fully human monoclonal antibody ...
Managed Healthcare Executive

Regeneron’s Libtayo FDA Approved as First Immunotherapy to Reduce Recurrence of High-Risk Squamous Cell Skin Cancer

Libtayo gained FDA approval as the first immunotherapy for high-risk cutaneous squamous cell carcinoma, promising improved ...

Regeneron Gets CHMP Backing for Expanded Libtayo Use in Skin Cancer

Regeneron Pharmaceuticals said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended expanded approval of its blockbuster cancer drug Libtayo for certain ...
Zacks Investment Research on MSN

Regeneron Gets FDA Nod for Label Expansion of Oncology Drug Libtayo

Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has approved the label expansion of PD-1 inhibitor Libtayo ...

Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery ...

In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance ...

Regeneron's Libtayo Gains FDA Approval To Reduce Recurrence Risk In Skin Cancer Patients

FDA approves Regeneron's Libtayo for adults with high-risk cutaneous squamous cell carcinoma after surgery and radiation, ...
BioSpace

FDA Hands Out First Commissioner’s Priority Vouchers to Regeneron, Sanofi, Disc, Others

The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting ...
Stocktwits on MSN

Retail Buzz Builds Around Regeneron After FDA Clears Libtayo For High-Risk Skin Cancer; Traders Eye ‘Buying Opportunity’

Retail chatter picked up around Regeneron Pharmaceuticals late Wednesday after the U.S. Food and Drug Administration (FDA) ...
Fierce Pharma

Novo plant hit with FDA's most serious inspection classification, portending possible delays for partners

It appears problems at Novo Nordisk’s recently acquired manufacturing facility in Indiana aren’t going to be solved any time ...

Regeneron's drug becomes first FDA-approved Ebola virus treatment

The U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals' triple antibody cocktail as the first Ebola virus treatment, lending validation to similar drugs being developed ...

Regeneron (REGN): Reevaluating Valuation Following Breakthrough Trial Results and Evkeeza’s FDA Pediatric Approval

Regeneron Pharmaceuticals (REGN) has grabbed investor attention this week, as recent positive late-stage clinical data and a ...