First doses will be available in the Fall. British drugmaker GlaxoSmithKline (GSK) announced this week that the Food and Drug Administration (FDA) has approved their respiratory syncytial virus…
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FDA Approves Cell Therapy for Blood Cancer Patients
Cell therapy has the potential to reduce the risk of infection after stem cell transplants. The U.S. Food and Drug Administration (FDA) recently approved Omisirge (omidubicel-onlv), a donor-modified…
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FDA Issues Recall for Some CPAP Machines
43 complaints were received on certain Philips models, leading to Class I recall. The Food and Drug Administration (FDA) issued a Class I recall, the most serious type,…
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DOJ Appeals Abortion Drug Suspension
The abortion drug was approved by the FDA in 2000. The Department of Justice filed an appeal this week, requesting that the 5th Circuit Court of Appeals review…
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FDA Approves Over-The-Counter Opioid Overdose Reversal Spray
Agency approves the first overdose reversal drug to be available without a prescription The Food and Drug Administration (FDA) approved the opioid reversal drug Narcan for over-the-counter sales,…
Read MoreFDA Approves Second Lab-Grown Chicken Product
Sends GOOD Meat a “no-questions” conclusion. The Food and Drug Administration (FDA) approved GOOD Meat’s lab-grown chicken for U.S. marketplaces last week, sending GOOD Meat a “no-questions” letter…
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Federal Judge Expects Ruling Soon on Abortion Pill
FDA approval and authority are at issue. The Food and Drug Administration has a process for approving or recalling a drug in the marketplace. Their authority has been…
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State AGs Meet to Discuss Abortion Pill Block Case
A lawsuit challenges the FDA approval process in 2000. Attorneys general from 44 states recently met to discuss a lawsuit filed against the Food and Drug Administration (FDA)…
Read MoreFDA Allows Retail Sale of Abortion Pills
Pharmacies are now allowed to apply for certification for dispense. The Food and Drug Administration (FDA) has fully approved abortion pill access through retail pharmacies for the first…
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Congress Issues Report on FDA’s Aduhelm Approval
House committees are concerned with the atypical protocol that was followed. Two House committees published a report at the end of the year highlighting the irregular means the…
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