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The drug, called Makena, was intended to stop premature births, but has not been effective in its goal, says the FDA.

The FDA agreed to review a supplemental Biologics License Application for Opdivo to treat stage 2B or C, fully resected melanoma.

Voxzogo is already available for patients over 5 years with a genetic cause of dwarfism. The PDUFA date is set for Oct. 21, 2023, and will potentially expand the drug to children 5 and under.

The drug, manufactured by Sandoz, will treat conditions including osteoporosis in postmenopausal women

Results of an analysis of the VOYAGER PAD clinical trial were presented at ACC.23.

A single oral dose of azithromycin during labor in women planning vaginal delivery can significantly reduce the risk of maternal sepsis or death

The test is intended to complement the company’s TBI plasma test, which received FDA clearance in 2021.

The safety of gel manicures is under renewed scrutiny after a new study suggested they can cause DNA damage

Significant differences in the use of insulin pump and/or CGM technology were noted based on demographic and socioeconomic factors

Endometriosis has been linked with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease, but more definitive research is needed

Now that more states are legalizing cannabis for medical and recreational use, pharmacists must step up to educate and counsel customers on safe use

Convatec’s InnovaBurn is the first product of its kind intended to help patients manage burns and wounds.

Your weekly roundup of the latest news from Drug Topics®.

VP-102 hopes to treat molluscum contagiosum, pending approval from FDA

The pharmaceutical giant announced a 70% price reduction for most of its commonly sold insulin.

CMS has no plans to change their coverage and approval process, which the Alzheimer's Association believes is standing between patients and treatment.

Efanesoctocog alfa is a recombinant factor VIII therapy with once-a-week dosing.

The vaccine would be administered to pregnant people to protect newborns from RSV.

Leading health organizations are urging those with diabetes and other chronic conditions to get the influenza vaccine.

Pharmacists generally agree that domestic production of the commonly used antibiotic could prevent more shortages from happening in the future

As inflation rises, consumers are beginning to lose confidence in their ability to cover health care expenses.

Not only were people with newly diagnosed type 2 diabetes less likely to develop dementia if they took pioglitazone, but the benefit was stronger among patients with a history of ischemic heart disease or stroke.

Two studies found digital therapeutics can help patients manage their type 2 diabetes effectively regardless of race or ethnicity.

Collections of oncology drugs in 13 states are being redistributed to patients in need.

Analysts have identifed treatments that may deliver annual sales topping $1 billion over the next 5 years.

The founder of Mark Cuban Cost Plus Drug Company called drug pricing "insane" during a fireside chat at the Association of Accessible Medicines annual meeting.

Anacaulase-bcdb improves current standard of care for deep partial thickness and/or full thickness thermal burns.

At the upcoming hearing, the committee will examine the impact of PBMs on access to healthcare and the Pharmacy Benefit Manager Transparency Act which was submitted by Sens. Maria Cantwell and Chuck Grassley.

After being FDA approved in 2021, tezepelumab (Tezspire) has been approved again for self-administration.

Sacituzumab govitecan significantly improved overall survival over the comparator chemotherapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative breast cancer who had received prior treatment.