News

FDA willing to trade faster drug reviews for lower prices, Bloomberg reports
FDA Commissioner Marty Makary said the agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost ...
sharewise22h
FDA Accepts Merck's Filing for Two-Drug, Once-Daily HIV Pill
Merck MRK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its ...
Merck: FDA to Review Doravirine/Islatravir Regimen in HIV-1 Infection
Merck on Thursday said the application covers the investigational, once-daily, oral two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The ...
Healio1d
FDA accepts new supplemental biologics license application for review for Winrevair
The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...
Merck granted FDA priority review for Winrevair label update
Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted priority review for its request ...
FDA Grants Priority Review for Merck & Co’s (MRK) WINREVAIR
Merck & Co., Inc. (NYSE:MRK) is one of the 10 Best Dip Stocks to Buy According to Billionaires. On July 2, Merck & Co., Inc. ...
Medical Dialogues1d
Merck application for two drug regimen for adults with virologically suppressed HIV 1 infection under USFDA review
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration ...
The Pharma Letter2d
Merck & Co’s NDA for HIV regimen accepted by FDA
The US Food and Drug Administration (FDA) has accepted for review Merck & Co’s New Drug Application (NDA) for ...
Dealbreaker on MSN1d
Merck Breathes Life Into Its Respiratory Prospects With $10B Deal to Buy Verona Pharma
Verona Pharma brings to Merck the inhaled drug Ohtuvayre, which is FDA approved as a treatment for chronic obstructive ...
PharmExec5d
FDA Grants Priority Review to Merck’s Winrevair Label Update for Pulmonary Arterial Hypertension to Reflect Risk Reduction Benefits
Results from the Phase III ZENITH trial show that patients treated with Winrevair (sotatercept-csrk) for pulmonary arterial ...
Managed Healthcare Executive1d
FDA Accepts NDA for Investigational HIV Regimen, Doravirine/Islatravir
If approved, doravirine/islatravir would be the first two-drug HIV treatment regimen without an integrase inhibitor, ...
Morningstar2d
Merck: FDA to Review Doravirine/Islatravir Regimen in HIV-1 Infection
Merck & Co. said the U.S. Food and Drug Administration will review its application seeking approval of its proposed doravirine/islatravir regimen in certain adults with HIV-1 infection. Merck on ...