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ViiV Healthcare announced that the FDA approved Apretude, a long-acting injectable pre-exposure prophylactic option to reduce the risk of sexually acquired HIV-1.
Going through the most newsworthy stories of the year, BioSpace found trends more than one big story, topics that just kept rising again and again. Here’s a look.
Mergers and acquisitions are part of the lifeblood of the pharmaceutical industry, as companies flex their pocketbooks to acquire pipelines and talent to bolster and complement their own programs.
Nasal spray vaccine delivery for COVID-19 has been explored by multiple companies since the beginning of the pandemic.
Moderna has decided to drop the patent application to “allow more time for discussions with the NIH”, which will be aimed at an amicable resolution.
Shares of Coherus BioSciences are climbing in premarket trading after the company announced the FDA greenlit the company’s Humira biosimilar Yusimry.
Biogen announced that effective January 1, 2022, it will cut the wholesale acquisition cost of its Alzheimer’s drug Aducanumab in half from $56,000 to $28,200 per patient per year.
As the spread of the Omicron variant of COVID-19 picks up speed, vaccine makers are rushing to test their shots against the new mutation, with mixed results.
Novartis announced it has licensed BeiGene’s ociperlimab, a late-stage TIGIT inhibitor, to bolster its immunotherapy pipeline.
On Monday, Intra-Cellular Therapies announced that the FDA has approved CAPLYTA to treat the deep depressive episodes of patients with bipolar I or II.
The year kicked off with a bang as multiple companies raced to a public listing.
The decision comes after the FDA granted the drug, Tezspire (tezepelumab), Priority Review status on positive results from the PATHFINDER clinical trial program.
VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker to be approved by the FDA.
After their latest trial delivered disappointing results, Pfizer and BioNTech are ready to test if a third dose of their COVID-19 vaccine would trigger an immune response in very young children.
Here’s a look at 10 of the more compelling research stories of the year.
On December 28, the U.S. Food and Drug Administration reported there had been 50 novel drug approvals for the year, and that was just for new chemical entities.
The findings may have far-reaching consequences for any COVID-19 vaccines in development that are based upon targeting the well-conserved SARS-CoV-2 nucleocapsid (N-) protein.
Shares of Global Blood Therapeutics were up more than 10% in late-afternoon trading following regulatory approval of a supplemental New Drug Application for oral Oxbryta (voxelotor) tablets for the treatment of pediatric sickle cell disease.
Although the U.S. FDA largely cleared its calendar ahead of the holidays, it still has a couple open PDUFA dates leading up to January 1, 2022. Here’s a look.
It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look.