NDA News-CliniExpert

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

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

FDA Approves Voxzogo (vosoritide) to Increase Linear Growth in Children with Achondroplasia

SAN RAFAEL, Calif., Nov. 19, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOXZO