The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) both confirmed they are investigating two separate Listeria bacteria outbreaks linked to packaged salads. Two companies, Dole Fresh Vegetables and Fresh Express, voluntarily recalled packaged salad products in connection to the Listeria monocytogenes contamination. The CDC said that at least three deaths have…
FDA Authorizes Merck’s COVID-19 Pill Weeks After US Makes $2.2 Billion Purchase
The Food and Drug Administration (FDA) on Thursday morning issued an emergency use authorization for Merck’s antiviral pill for COVID-19, more than 12 hours after giving the green light for a similar, oral drug made by Pfizer. Merck’s drug, named molnupiravir, was developed with Ridgeback Biotherapeutics, and it was shown to reduce hospitalizations and deaths from…
FDA Approves First Injectable Medication to Lower HIV Risk
The U.S. Food and Drug Administration on Monday approved the first injectable medication to lower the risk of contracting HIV, or the human immunodeficiency virus. HIV attacks the body’s immune system and causes AIDS (acquired immunodeficiency syndrome) if not treated. The FDA-approved medication is an injectable form of GlaxoSmithKline Plc’s cabotegravir drug. The injection, called Apretude (cabotegravir extended-release injectable suspension),…
The Week Ahead in Biotech (Dec. 19–25): Amgen and Aquestive Regulatory Decisions Key Events of Holiday-Shortened Week
Biotech stocks reversed course and advanced solidly in the week ending Dec. 17, as an increase in risk aversion pushed investors to buy into defensive stocks. The sector also drew strength from some positive stock-specific news. Among the regulatory decisions for the week, the Food and Drug Administration gave the green light to argenx SE’s efgartigimod for…
Pushback to US Health Agencies Grows Over Handling of COVID-19 Vaccine Boosters
Pushback to two top U.S. health agencies is growing over how officials handled clearing and recommending COVID-19 vaccine boosters. The Food and Drug Administration (FDA) last month authorized boosters of all three vaccines available in the United States for all adults. Soon after, the Centers for Disease Control and Prevention (CDC) recommended any American 18…
US FDA Approves AstraZeneca-Amgen Drug for Severe Asthma
The U.S. Food and Drug Administration (FDA) approved AstraZeneca and Amgen’s drug, Tezspire, to treat severe asthma for those aged 12 years and older, the companies said on Friday. The approval is based on late-stage trial data that showed the drug cut the rate of asthma attacks by 56 percent among patients when compared with…
US Health Regulator Flags Concerns at Medtronic’s Diabetes Business
The U.S. health regulator has issued a warning letter to Medtronic Plc, highlighting certain concerns related to medical device quality management at its diabetes business, the company said on Wednesday. Medtronic’s shares were down 6 percent at $104.95 in early trading, hitting their lowest in over a year. The Food and Drug Administration’s (FDA) letter…
FDA Now Allows an Abortion Pill to Be Sent by Mail, Removing In-Person Dispensing Requirement
The Food and Drug Administration (FDA) announced a lift on restrictions on mifepristone, allowing doctors to issue online prescriptions for abortion pills and have them mailed to patients or local pharmacies. The pill—referred to as RU-486 or Mifeprex, or by its generic name mifepristone—is used to terminate early pregnancies up to 10 weeks after conception. It is…
US FDA Approves Eagle’s Generic Version of Endo Blood Pressure Drug
Eagle Pharmaceuticals Inc said on Wednesday the U.S. health regulator approved its generic version of Endo International’s blood pressure drug, Vasostrict, sending its shares to a more than one-month high. The U.S. Food and Drug Administration’s approval comes just months after a Delaware federal court ruled that Eagle’s proposed generic, vasopressin, did not infringe on…
FDA Strengthens Warning Over Severe Condition Linked to Johnson & Johnson’s COVID-19 Vaccine
U.S. drug regulators this week formally strengthened a warning to Americans regarding a severe condition linked to Johnson & Johnson’s COVID-19 vaccine. Blood clots and low blood platelet levels, known as thrombosis with thrombocytopenia syndrome (TTS), are now listed as a contradiction, or a medical reason for somebody not to get the shot. “Do not administer” the…
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