Biogen Q4 Earnings Review: Why I'm Calling Time On This 'Powder Puff' Pharma
Biogen’s disappointing Leqembi performance and weak pipeline hurt future growth. Learn why BIIB stock is rated "sell" due to ...
pharmaphorum2 天
With Merck circling, SpringWorks gets new drug approval
Stamford, Connecticut-based SpringWorks' Gomekli (mirdametinib) has become the first medicine approved for both adults and ...
clinicalpainadvisor.com7 天
FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
Nuvation Bio: Pending Approval Shot In ROSL+ NSCLS Looks A Major Upside Catalyst
Nuvation has a best-in-class lung cancer drug that could be approved in the US in June. Read why I'm bullish on the stock ...
The FDA just approved a new painkiller. Is it too good to be true?
Meet suzetrigine, a non-opioid that promises to avoid addiction risk. But some experts say it can't replace opioids ...
BioSpace2 天
Anticipating Approval, Gilead Gears Up for Mid-Year Launch for Lenacapavir PrEP
Gilead beat consensus estimates in Q4 with $7.6 billion in revenue, driven largely by its HIV drug Biktarvy and CAR T therapies Trodelvy and Yescarta.
Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application ...
Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has ...
BioWorld9 天
Accelerated approval, mRNA therapies in recent UK drug regulations
The U.K. is continuing to shape up regulation, adding reform of its accelerated drug approval process and its draft guidance on personalized mRNA cancer vaccines to new clinical trial regulations that ...