Category Press Releases

Vertex Receives CHMP Positive Opinion for the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment…

Read MoreVertex Receives CHMP Positive Opinion for the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN). Treatment with all doses of VX-548 resulted in a statistically significant and…

Read MoreVertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy

Positive CHMP Opinion by EMA for Arpraziquantel to Treat Schistosomiasis in Preschool-Aged Children

Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis…

Read MorePositive CHMP Opinion by EMA for Arpraziquantel to Treat Schistosomiasis in Preschool-Aged Children

CHMP Issues Positive Opinion for Biogen’s SKYCLARYS®, the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease

Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in people aged 16 years and older. If approved…

Read MoreCHMP Issues Positive Opinion for Biogen’s SKYCLARYS®, the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease

ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.

Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product…

Read MoreZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.

IPA Announces Closing of $1.265 Million Public Offering of Common Shares

ImmunoPrecise Antibodies Ltd. (NASDAQ: IPA) (“ImmunoPrecise” or “IPA” or the “Company”), today announced the closing of its $1.265 million underwritten public offering of 1,265,000 common shares, including 165,000 common shares issued pursuant to the full exercise by the underwriter of…

Read MoreIPA Announces Closing of $1.265 Million Public Offering of Common Shares

Merck Announces KEYLYNK-008 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LYNPARZA® (olaparib) for Patients With Metastatic Squamous Non-Small Cell Lung Cancer to Stop for Futility

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYLYNK-008 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, for the treatment…

Read MoreMerck Announces KEYLYNK-008 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LYNPARZA® (olaparib) for Patients With Metastatic Squamous Non-Small Cell Lung Cancer to Stop for Futility

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab). ELREFXIO is a targeted immunotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior…

Read MoreEuropean Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

Sanofi Pipeline Transformation to Accelerate Growth Driven by Record Number of Potential Blockbuster Launches, Paving the Way to Industry Leadership in Immunology

 Today Sanofi is hosting an Investor R&D Event in New York providing updates and insight into its innovative pipeline and new growth drivers. Focusing on its unprecedented portfolio of 12 new molecular entities with blockbuster potential, including multiple late-stage assets, the…

Read MoreSanofi Pipeline Transformation to Accelerate Growth Driven by Record Number of Potential Blockbuster Launches, Paving the Way to Industry Leadership in Immunology

Vertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announced today that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 genome-edited cell therapy, for the treatment of sickle cell disease (SCD) in patients 12 years and older…

Read MoreVertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease

Gilead’s Leadership in Metastatic Breast Cancer Showcased With New Trodelvy Data at San Antonio Breast Cancer Symposium 2023

Gilead Sciences, Inc. (Nasdaq: GILD) today announced it will present new data at San Antonio Breast Cancer Symposium (SABCS) 2023, supporting the use of Trodelvy® (sacituzumab govitecan-hziy) in certain metastatic triple-negative breast cancer (mTNBC) and pre-treated HR+/HER2- metastatic breast cancer (mBC)…

Read MoreGilead’s Leadership in Metastatic Breast Cancer Showcased With New Trodelvy Data at San Antonio Breast Cancer Symposium 2023