FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Has the U.S. Food and Drug Administration failed to do its due diligence in finding and reporting financial conflicts of interest between members of its scientific advisory committees and pharmaceutical companies?
Merz Neurosciences announced that the U.S. Food and Drug Administration approved a treatment for chronic drooling in adults.
Shares of Alkermes plc are climbing in premarket trading after the company announced the U.S. Food and Drug Administration approved Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.
Shares of Menlo Park, Calif.-based Dermira jumped more than 10 percent this morning after the U.S. Food and Drug Administration (FDA) approved its therapy for people who have excessive underarm sweating.
After failing to gain market share under the umbrella of Valeant Pharmaceuticals, Addyi is getting a relaunch at half the price.
Array BioPharma, Inc. secured approval for its combination treatment for BRAF-mutant metastatic melanoma.
Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain.
Shares of Achaogen are down more than 19 percent in early trading after the FDA handed down a split approval and rejection of Zemdri (plazomicin) for the treatment of complicated urinary tract infections and bloodstream infection, respectively.
The FDA accepted Genentech’s New Drug Application (NDA) for baloxavir marboxil, a single-dose, oral flu treatment for people 12 years and older. It also granted it Priority Review.
In a first of its kind ruling, the U.S. Food and Drug Administration approved GW Pharmaceuticals’ Epidiolex, a cannabis-based treatment for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome.