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Kevin Dunleavy

Kevin Dunleavy

Staff Writer at FiercePharma

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Location
United States
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  • English
Covering topics
  • Health & Medicine

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Recent Articles

fiercepharma.com

AZ, Daiichi score with FDA nod for Enhertu combo in 1st-line breast cancer

After AstraZeneca and Daiichi Sankyo made waves in June with eye-opening results for Enhertu in a combination treatment for a particular type of breast cancer, the companies have scored an FDA appr | The FDA has approved Enhertu combined with Roche’s Perjeta as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. The combo was shown to reduce disease progression or death risk by 44% compared to standard of care in a late-stage study.
8 days ago
fiercepharma.com

Once public, now private, Gamida Cell scores 2nd FDA nod for stem c...

Gamida Cell has scored an expansion for Omisirge, with the FDA
14 days ago
fiercepharma.com

Roll Tide: Lilly selects Alabama site as location for $6B API facility

Eli Lilly has unveiled the location of the third of its four large-scale manufacturing facilities that it plans to build in the U.S. | Eli Lilly has unveiled the location of the third of its four large-scale manufacturing facilities planned for the U.S. The drugmaker has selected Huntsville, Alabama, as the site of a $6 billion plant that will produce APIs for small molecule and peptide medicines.
14 days ago
fiercepharma.com

BMS scores 5th indication for Breyanzi with FDA marginal zone lymph...

With FDA approval to treat marginal zone lymphoma (MZL), Bristol Myers Squibb’s Breyanzi has become the first CAR-T therapy in the indication, as well as the first CAR-T to reach the market for fiv | With FDA approval to treat marginal zone lymphoma, Bristol Myers Squibb’s Breyanzi has become the first CAR-T therapy in the indication, as well as the first CAR-T to reach the market for five different types of blood cancer.
18 days ago
fiercepharma.com

Lowering FDA fees would spur generics manufacturing in US, Mark Cub...

President Donald Trump has been successful in convincing many of the world’s top drugmakers to commit to manufacturing more of their prescription treatments in the U.S. | Mark Cuban, the co-founder of online pharmacy Cost Plus Drugs, says his company would produce generic drugs in the U.S. if the FDA eliminated approval fees.
18 days ago
fiercepharma.com

FDA leadership churn continues with transfer of OTC drug office dir...

One day after the FDA’s new director of the Center for Drug Evaluation and Research (CDER), Richard Pazdur, M.D., informed colleagues of his sudden and unexpected
19 days ago
fiercepharma.com

Cosmo shares zoom with results from 2 male-pattern hair loss trials

Cosmo Pharmaceuticals has
20 days ago
fiercepharma.com

FDA's Prasad tells staffers agency plans to get tougher on vaccine ...

The FDA is planning to tighten its regulations for vaccines, according to an internal email sent by Vinay Prasad, M.D., who heads up the agency’s Center for Biologics Evaluation and Research (CBER) | The FDA is planning to tighten its regulations for vaccines, according to an internal email sent by Vinay Prasad, M.D., who heads up the agency’s Center for Biologics Evaluation and Research (CBER).
22 days ago
fiercepharma.com

Medicare unveils price reductions for 15 drugs, including Novo's se...

The United States has revealed price reductions for the second round of | The U.S. has revealed price reductions for the second round of prescription drugs negotiated by Medicare through the Inflation Reduction Act (IRA). Headlining the list of 15 treatments that will undergo price reductions in 2027 are Novo Nordisk’s semaglutide products, Ozempic and Wegovy.
27 days ago
fiercepharma.com

French authorities raid Sanofi headquarters in tax fraud probe

More than 30 agents conducted a surprise raid of Sanofi’s headquarters in Paris on Tuesday morning as part of a tax fraud investigation, according to a 
27 days ago
fiercepharma.com

Novartis to cut 550 jobs at plant in Switzerland by end of 2027

Less than a week after Novartis unveiled a plan to establish | Less than a week after Novartis unveiled a plan to establish a “flagship manufacturing hub” in North Carolina that would add 700 employees to its rolls, the Swiss drugmaker says it is making moves in its home country that will eliminate 550 jobs at one site and add 80 at another location.
28 days ago