The fast-spreading BA.4 and BA.5 sub-variants of Omicron are estimated to make up a combined 52% of the coronavirus cases in the United States as of June 25, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.
U.S. regulators plan to decide by early July on whether to change the design of COVID-19 vaccines this fall in order to combat more recent variants of the coronavirus, with hopes of launching a booster campaign by October, a top Food and Drug Administration official said on Tuesday.
The European Union’s drug regulator said on Tuesday it has started a review to extend the use of Bavarian Nordic’s (BAVA.CO) smallpox vaccine to prevent monkeypox disease as well.
Oklahoma has reached a $250 million settlement with AmerisourceBergen Corp., Cardinal Health Inc., and McKesson Corp. to resolve allegations the drug distributors contributed to the opioid epidemic in the state, Oklahoma Attorney General John O’Connor said on Monday.
A U.S. appeals court panel said on Monday it would convene a full panel to reconsider President Joe Biden’s executive order requiring civilian federal employees to be vaccinated against COVID-19, and set aside the order pending that hearing.
The U.S. Food and Drug Administration (FDA) declined to approve Spero Therapeutics Inc.’s oral antibiotic drug for the treatment of patients with complicated urinary tract infections, the company said on Monday.
The U.S. Supreme Court on Monday gave two doctors found guilty of misusing their licenses in the midst of the U.S. opioid epidemic to write thousands of prescriptions for addictive pain medications another chance to challenge their convictions.
“We expect that this acquisition and Ipsen’s commitment to invest in the oncology space will ensure our epigenetic pipeline continues to advance in a way we could not have done on our own to bring transformative cancer therapies to patients in need,” Bogle said in a statement,” company CEO David Loew said in a statement.
The proposed rule is intended to increase options for the development of safe and effective nonprescription drugs, according to the agency.
The U.S. Food and Drug Administration has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event (SAE).