A CRL is a communication from the FDA that the agency cannot approve a pending regulatory application before it in its present form.
Amgen’s weight-loss drug candidate MariTide is meant to be administered subcutaneously monthly or less frequently in obese or overweight patients without Type 2 diabetes.
he new proposal would expand access to medications for obesity, and help an estimated 3.4 million Americans with Medicare.
Last month, Scholar Rock achieved the primary endpoint in the company's own Phase 3 trial of apitegromab in SMA patients.
Citi noted the positive clinical data and the competitive pricing of Attruby at $225,000 per year, below Pfizer’s tafamidis.
Replimune’s lead asset RP1 is based on a proprietary new strain of Herpes simplex virus engineered to maximize tumor killing potency.
The biotech sector's breakout attempt post-election reversed sharply, with ETFs like IBB and XBI falling and invalidating the long-term bullish setup.
Disappointing retail earnings and concerns about bloated valuations are weighing down on retail sentiment toward some stocks.
Retailers went overboard about a couple of biotech stocks and a MedTech name, among others on Wednesday.
After the best week of 2024 on excitement over President-elect Trump’s policies, Wall Street lost momentum last week on sticky inflation and the Fed’s hawkish comments. The S&P 500 dropped more than...