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
FDA Approves Besremi (ropeginterferon alfa-2b-njft) for the Treatment of Adults With Polycythemia Vera
BURLINGTON, Mass.--(BUSINESS WIRE) November 12, 2021 --PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific pri
FDA Approves Eprontia (topiramate) Oral Solution for Epilepsy and Preventive Treatment of Migraine
WOBURN, MA, November 8, 2021 – Azurity Pharmaceuticals, Inc. a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved
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