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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

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

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

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

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

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