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Reuters analyzed 55 novel drugs approved by the FDA last year, up from 37 in 2022. The agency's biologic division approved 17 new products, including four gene therapies.
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...
The drug was approved in January under the FDA’s Accelerated Approval pathway, which allows the organization to approve drugs for serious conditions where there is an unmet medical need, based ...
Just because the FDA approves a drug doesn’t necessarily mean that Medicare will pay for it for all patients. ... there may be a third Alzheimer’s drug hitting the market as early as this year ...
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with locally advanced or metastatic non- small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2] Tagrisso
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
This is a complete list of androgens/anabolic steroids (AAS) and formulations that are approved by the FDA Tooltip Food and Drug Administration and available in the United States. AAS like testosterone are used in androgen replacement therapy (ART), a form of hormone replacement therapy (HRT), and for other indications.
Lilly applied to the FDA for approval of the drug in July, ... a similar Alzheimer’s drug approved by the FDA last year. The FDA was initially set to decide on donamemab's approval by early next ...
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