Print this page INDIANAPOLIS, Sept. 3, 2020 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) today approved two additional doses of Eli Lilly and Company’s (NYSE: LLY) Trulicity® (dulaglutide). The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11. The phase 3 trial showed the additional doses led to
Drugs
maralixibat Treatment for Cholestatic Pruritus in Patients with Alagille Syndrome Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program Print this page FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep. 1, 2020– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on
FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer Print this page South San Francisco, CA — September 4, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib)
Treatment for Prevention of Cisplatin-Induced Ototoxicity Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its NDA for Pedmark To Prevent Ototoxicity Associated With Cisplatin Print this page RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter
FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain Print this page ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ — Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults
September 8, 2020 Print this page Audience: Health Professional, Pharmacy September 8, 2020 — FDA is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug
September 3, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 3, 2020 — RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from
News FDA Alerts Corgiomed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL September 3, 2020 Print this page Audience: Consumer, Health Professional September 3, 2020 — CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer
FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency Print this page Plainsboro, NJ, Aug 28, 2020 – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Sogroya (somapacitan-beco) injection 10 mg/ 1.5 mL (6.7 mg/mL) for the replacement of endogenous growth
FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia Print this page PRINCETON, N.J.–(BUSINESS WIRE) September 1, 2020 –Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult
FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair Print this page ATHLONE, Ireland, Aug. 31, 2020 /PRNewswire/ — Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug Administration (FDA) has approved Xaracoll for acute
September 1, 2020 Print this page Audience: Consumers September 1, 2020 — The Protein Shoppe, LLC is voluntarily recalling all lots of “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active