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FDA Approves Leqvio (inclisiran), First-in-Class siRNA to Reduce Low-Density Lipoprotein Cholesterol (LDL-C)

With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction(1) Leqvio provides effective and sustained LDL-

FDA Approves Apretude (cabotegravir extended-release injectable suspension) for HIV Pre-Exposure Prophylaxis (PrEP)

LONDON--(BUSINESS WIRE) December 20, 2021 -- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) a

FDA Approves Vyvgart (efgartigimod alfa-fcab) for the Treatment of Generalized Myasthenia Gravis

Breda, the Netherlands—Dec. 17, 2021 -- argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and ca

FDA Approves Tezspire (tezepelumab) for Severe Asthma

17 December 2021 -- AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with s

FDA Approves Yusimry (adalimumab-aqvh), a Biosimilar to Humira

REDWOOD CITY, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) appro

FDA Approves Dartisla ODT (glycopyrrolate) for Use in the Treatment of Peptic Ulcer

Parsippany, New Jersey December 17, 2021 -- Edenbridge Pharmaceuticals, LLC today announced that it has received approval from the U.S. Food and Drug Administration on its 505(b)(2) New Drug Applicati

ViaCyte's Stem Cell-Derived Treatment for Type 1 Diabetes Shows Promising Results in Two Published Studies

SAN DIEGO, Dec. 2, 2021 -- ViaCyte, Inc., a clinical-stage regenerative medicine company focused on developing novel cell replacement therapies to address diseases with significant unmet needs, announ

Novavax Statement on Omicron Variant Response

December 2, 2021 -- Novavax is rapidly responding to the emergence of the latest potential threat of the SARS-CoV-2 Omicron (B.1.1.529) variant of concern (VoC). The company is executing a two-pronged

Preclinical Data Demonstrate Sotrovimab Retains Activity Against Key Omicron Mutations, New SARS-CoV-2 Variant

Preclinical data demonstrate sotrovimab, authorised in multiple countries around the world, retains activity against all tested variants of concern, including key mutations of Omicron Data to be confi

Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD

CAMBRIDGE, Mass. – December 1, 2021 -- Sage Therapeutics, Inc. (Nasdaq: SAGE), and Biogen Inc. (Nasdaq: BIIB) today announced 12-month data for the cohort of patients (n=199), who received zuranolone

Insightec Announces FDA Clearance For Exablate Prostate To Treat Prostate Tissue

HAIFA, Israel and MIAMI, Fla., Dec. 1, 2021 -- Insightec, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced toda

FDA Approves Entadfi (finasteride and tadalafil) as a New Treatment for Benign Prostatic Hyperplasia

MIAMI, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, an