Industry

TRYNGOLZA™ (olezarsen) approved in U.S. as first-ever treatment for adults living with FCS

CARLSBAD, Calif., December 19, 2024 -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA™ (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare,... Continue Reading

AMGEN ANNOUNCES ROBUST WEIGHT LOSS WITH MARITIDE

THOUSAND OAKS, Calif., Nov. 26, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive data at 52 weeks in a double-blind, dose-ranging Phase 2 study with MariTide (maridebart cafraglutide, formerly AMG 133), an investigational antibody peptide conjugate subcutaneously administered... Continue Reading

Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA

PALO ALTO, Calif., Nov. 22, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a new type of biopharmaceutical company focused on genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Attruby™ (acoramidis), an... Continue Reading

Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes

PALO ALTO, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, presented positive initial outcomes from the ATTRibute-CM open-label extension... Continue Reading

BridgeBio Shares Recurrent Event Analysis of ATTRibute-CM, Demonstrating a 42% Reduction by Acoramid

PALO ALTO, Calif., Sept. 27, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, presented a post-hoc analysis evaluating the effect of acoramidis on the... Continue Reading

Novartis twice-yearly* Leqvio® demonstrated clinically meaningful, statistically significant...

Basel, August 28, 2024 – Novartis announced today positive topline results from twice-yearly* Leqvio® (inclisiran) in the Phase III V-MONO study, which met its primary endpoints. Leqvio monotherapy achieved clinically meaningful and statistically significant low-density lipoprotein... Continue Reading

Arrowhead Pharmaceuticals Reports Successful Topline Results for Plozasiran from the Pivotal Phase 3

Arrowhead Pharmaceuticals Reports Successful Topline Results for Plozasiran from the Pivotal Phase 3 PALISADE Study in Patients with Familial Chylomicronemia Syndrome Continue Reading

BridgeBio Pharma to Present Additional Analyses from the Phase 3 ATTRibute-CM Study of Acoramidis

BridgeBio Pharma to Present Additional Analyses from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at the 2024 ISA Meeting Continue Reading

Walgreens and Boehringer Ingelheim Are Partnering to Improve Diversity in Clinical Trials

Walgreens and Boehringer Ingelheim today announced a strategic collaboration aimed at optimizing recruitment and making clinical trials more accessible, inclusive and equitable. This collaboration will offer people an opportunity to learn about and potentially participate in an important Phase... Continue Reading

Medicare plans can now cover Wegovy for patients at risk of heart disease

For the first time, Medicare will allow coverage of one of the new blockbuster weight-loss drugs for enrollees in Part D plans. The plans may now cover Wegovy when prescribed to prevent heart attacks and strokes, according to a new policy issued this week from the Centers for Medicare and... Continue Reading

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiova

ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets based... Continue Reading

PRALUENT® (ALIROCUMAB) INJECTION RECEIVES FDA APPROVAL TO TREAT CHILDREN WITH GENETIC FORM OF HIGH C

TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering... Continue Reading