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The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
Tuesday, Ascendis Pharma A/S (NASDAQ:ASND) announced that the FDA extended the review date for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism. Hypoparathyroidism is an ...
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]
Pfizer's shot, Prevnar 20, was approved in 2021 for use in adults aged 18 years or older and protects against 20 serotypes. It is also approved for use in six-weeks old infants to 17-year olds.
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years. Cobenfy, manufactured by Bristol Myers Squibb ...
The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [10] The prescribing information is widely available on the web from the FDA, [11] drug manufacturers, and frequently inserted into drug packages. The main purpose of a drug label ...
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday approved two close copies of Regeneron Pharmaceuticals' Eylea, its first-ever clearance to biosimilar versions of the blockbuster ...