New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV (casirivimab and imdevimab) to Prevent SARS-CoV-2 Infection

TARRYTOWN, N.Y., Aug. 4, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine (NEJM) published positive detailed results from a

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Complete Response Letter Received from FDA for Treosulfan

TORONTO and CHICAGO and WEDEL, Germany, Aug. 03, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSX: MDP) (OTCQX: MEDXF) and medac GmbH (“medac”) announced today t

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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

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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

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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 (

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

INDIANAPOLIS, July 29, 2021 /PRNewswire/ -- Today at the Alzheimer's Association International Conference© (AAIC© 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of

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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

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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

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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

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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

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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

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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

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