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FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
WJET - WFXP Erie· 19 hours agoToday, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. "Many rare conditions ...
FDA accepts Sanofi’s Sarclisa sBLA for priority review
Pharmaceutical Technology via Yahoo Finance· 1 day agoThe US Food and Drug Administration (FDA) has accepted for priority review Sanofi's supplemental...
US FDA approves Amgen's biosimilar to AstraZeneca's rare blood disorder treatment
Reuters via Yahoo News· 19 hours agoAmgen's drug will be marketed under the name Bkemv. Biosimilars are close copies of complex...
Psychoactive Drugs Are Having a Moment. The FDA Will Soon Weigh In.
The Gilmer Mirror· 12 hours agoLori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved their lives. Raised in New Orleans by a mother with untreated bipolar disorder who later killed ...
Milestone Pharma's NDA For Cardamyst Spray Gets FDA Acceptance, Shares Up
RTT News· 5 hours agoMilestone Pharmaceuticals Inc. (MIST) Wednesday announced that the FDA has accepted the Company's New Drug Application or NDA for Cardamyst nasal spray to manage paroxysmal supraventricular tachycardia or PSVT.
Nearly 1.9 million bottles of water impacted by FDA recall pose ‘no health or safety risk’: company
WPIX New York City, NY via Yahoo News· 4 days agoThe FDA has determined thousands of cases of bottled water affected by a March recall are "not...
FDA greenlights pump-controlling artificial pancreas app that covers pregnant women with Type 1...
FierceBiotech· 1 day agoThe FDA delivered a green light to its first closed-loop, insulin pump-controlling smartphone app...
Verona prepares for anticipated US launch of ensifentrine for COPD in Q3 2024
Pharmaceutical Technology via Yahoo Finance· 4 hours agoVerona Pharma has announced that it is finalising preparations for the potential US launch of...
FDA panel recommends approval of a blood test for colon cancer
NBC NEWS· 6 days agoIf approved, Shield could become the second blood-based test for colon cancer diagnosis in the...
Berkeley County receives $1.2 million in national opioid settlement
WCBD-TV Charleston· 21 minutes agoBERKELEY COUNTY, S.C. (WCBD) – Berkeley County has received $1.2 million as part of a national...