article thumbnail

With new FDA approval, Merck's Welireg takes another step toward blockbuster goal

Fierce Pharma

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely.

FDA 299
article thumbnail

Sarepta details Elevidys launch progress while awaiting key FDA decision on label expansion

Fierce Pharma

Despite a restricted FDA label, Sarepta Therapeutics has seen early commercial success with its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | The company is quickly moving through Elevidys' eligible patient population while awaiting the FDA's decision on a broader label.

FDA 187
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

New FDA head needs to examine the accelerated approval program

World of DTC Marketing

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

FDA 234
article thumbnail

The FDA and Aduhelm: WTF?

World of DTC Marketing

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. government. Natalie Shure, The New Republic.

FDA 218
article thumbnail

Regeneron touts launch of high-dose Eylea in battle with Roche's Vabysmo

Fierce Pharma

Roche’s surge in sales for its long-acting macular degeneration drug Vabysmo showed that patients in the market are open to switching to another treatment. After gaining FDA approval for its high-dose Eylea, Regeneron racked up $43 million in sales in the U.S.

Sales 210
article thumbnail

Promising Remote Patient Monitoring solution, Polso, Achieves 1st FDA Clearance

Legacy MEDSearch

took a step towards its vision of transforming chronic care management with Polso , the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). “FDA clearance is an important validation of our technology. ChroniSense Medical Ltd.

FDA 97
article thumbnail

FDA clears way for retail pharmacy sale of abortion pills

pharmaphorum

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

Retail 75