News
FDA panel backs atezolizumab for mTNBC – at least for now
- Author:
- Kerry Dooley Young
FDA advisers voted to keep in place an approval for atezolizumab in metastatic triple-negative breast cancer.
News
FDA scrutinizes cancer therapies granted accelerated approval
- Author:
- Kerry Dooley Young
The FDA is conducting a review of therapies granted accelerated approval for cancer indications.
News
J&J COVID-19 vaccine wins unanimous backing of FDA panel
- Author:
- Kerry Dooley Young
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already...
News
Biden administration nixes buprenorphine waiver, docs disappointed
- Author:
- Kerry Dooley Young
Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag “Xthexwaiver.”
News
Dr. Fauci sees ‘wake-up call’ in emergence of new virus variants
- Author:
- Kerry Dooley Young
“The virus will continue to mutate and will mutate for its own selective advantage,” said Anthony S. Fauci, MD...
News
President Biden kicks off health agenda with COVID actions, WHO outreach
- Author:
- Kerry Dooley Young
President Biden issued an executive order requiring masks and physical distancing in all federal buildings.
News
HHS will drop buprenorphine waiver rule for most physicians
- Author:
- Kerry Dooley Young
There were more than 83,000 deaths attributed to drug overdoses in the United States in the 12 months ending in June 2020.
News
Anaphylaxis cases after COVID-19 vaccine rising but still rare: CDC
- Author:
- Kerry Dooley Young
Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19...
News
Medicaid to cover routine costs for patients in trials
- Author:
- Kerry Dooley Young
A federal COVID-19 relief/annual spending package mandates that all state Medicaid programs cover routine...
News
CDC identifies next priority groups for COVID-19 vaccine
- Author:
- Kerry Dooley Young
ACIP said the next priority group, Phase 1b, should consist of what it called frontline essential workers, a group of about 30 million, and adults...
News
Second COVID-19 vaccine ready for use, CDC panel says
- Author:
- Kerry Dooley Young
Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the...
News
Moderna COVID-19 vaccine wins decisive recommendation from FDA panel
- Author:
- Kerry Dooley Young
The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo...
News
FDA panel supports expanded HF role for sacubitril/valsartan
- Author:
- Kerry Dooley Young
An FDA panel supported an expanded approval of sacubitril/valsartan based on new analyses of data from a preserved-EF heart failure trial, in...
News
FDA panel overwhelmingly backs emergency authorization for Pfizer COVID vaccine
- Author:
- Kerry Dooley Young
“I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own...
News
Medicare finalizes 2021 physician pay rule with E/M changes
- Author:
- Kerry Dooley Young
“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and...