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FDA Approves Nexviazyme (avalglucosidase alfa-ngpt) for Late-Onset Pompe Disease

PARIS – August 6, 2021 -- The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe

SpringWorks Therapeutics Announces Phase 1b/2a Clinical Trial of Mirdametinib in Patients with Advanced Solid Cancers Harboring MAPK-Activating Mutations

STAMFORD, Conn., Aug. 03, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients

FDA Expands Authorized Use of REGEN-COV (casirivimab and imdevimab)

TARRYTOWN, N.Y., July 30, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (

Lilly Releases Donanemab Data That Demonstrated Relationship Between Reduction of Amyloid Plaque and Slowing of Cognitive Decline

FDA Broadens Existing Emergency Use of Lilly and Incyte's Baricitinib in Patients Hospitalized with COVID-19 Requiring Oxygen

INDIANAPOLIS, July 29, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Autho

FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus

2 August 2021 -- AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving

Satsuma Pharmaceuticals Announces First Subject Randomized in SUMMIT™, a Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine

SOUTH SAN FRANCISCO, Calif., July 28, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal

Johnson & Johnson Statement on U.S. FDA Approval of Shelf Life Extension for Company’s COVID-19 Vaccine

NEW BRUNSWICK, N.J., July 28, 2021 -- We are pleased to confirm the U.S. Food & Drug Administration (FDA) has extended the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine to

New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition

NORTH CHICAGO, Ill., July 25, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating t

Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

WILMINGTON, Del.--(BUSINESS WIRE) July 23, 2021 -- Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regardi

Vaxzevria is Highly Effective After One Dose Against Severe Disease or Hospitalisation Caused by Beta and Delta Variants of Concern

Real-world data from Canada showed 82% and 87% effectiveness after one dose against hospitalisation or death caused by Beta/Gamma and Delta variants respectively 23 July 2021 -- Results from the Canad

Anthos Therapeutics' Novel Factor XI Inhibitor Abelacimab Significantly Outperforms Standard of Care Enoxaparin in Prospective Phase 2 Efficacy Research Published in NEJM

CAMBRIDGE, Mass., July 19, 2021 /PRNewswire/ -- Anthos Therapeutics, a clinical-stage biopharma company developing innovative therapies for cardiovascular and metabolic diseases, today announced final