Topic: FDA priority review
The agency modeled the voluntary regulatory process after its selective Breakthrough Devices Program.
Merck has a shot at becoming the first company to receive clearance to sell a vaccine against the virus in the U.S.
The purchase comes as AstraZeneca enters a 12-month period in which it plans to file for approval of about 10 assets.
Bristol-Myers Squibb is picking up Celgene's late-stage JAK inhibitor fedratinib in its $74 billion megamerger with the biotech.
Securing the status positions Sage to receive a decision from the FDA by the end of the year.
Spark Therapeutics agreed to sell its priority review voucher, good for four months off an FDA review, to Jazz Pharmaceuticals for $110 million.
AstraZeneca is seeking approval of moxetumomab pasudotox in HCL patients who have undergone at least two prior lines of treatment.
The priority review means Roche will learn what the FDA makes of the benefits and risks of emicizumab by Feb. 23.
Kite Pharma has secured a priority review at the FDA for its CAR-T candidate.
The FDA has granted priority review status to Bayer’s copanlisib, setting the PI3K inhibitor up to speed through the regulatory process in 6 months or less.