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

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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

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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

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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

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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

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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

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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

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FDA Approves Xaciato (clindamycin phosphate) Vaginal Gel as a Treatment for Bacterial Vaginosis

SAN DIEGO, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) approved Xaci

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FDA Approves PreHevbrio (Hepatitis B Vaccine (Recombinant)) for the Prevention of Hepatitis B in Adults

PreHevbrio™ is the only approved 3-antigen hepatitis B vaccine for adults in the U.S. VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerfu

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FDA Approves Cytalux (pafolacianine) Injection for Identification of Ovarian Cancer During Surgery

WEST LAFAYETTE, Ind., Nov. 29, 2021 /PRNewswire/ -- On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during su

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FDA Approves Livtencity (maribavir) for Post-Transplant Cytomegalovirus (CMV) Infection/Disease

- In the Phase 3 SOLSTICE study, more than twice the proportion of adult transplant recipients with refractory or resistant (R/R) CMV infection/disease achieved confirmed CMV DNA level <LLOQ at Wee

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FDA Approves Fyarro (sirolimus protein-bound particles) for the Treatment of Malignant Perivascular Epithelioid Cell Tumor (PEComa)

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa, an ultra-rare and aggressive form of sarcoma with a strong female predominance LOS ANGELES, Nov. 23, 202

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