FDA denial could delay launch of Minerva’s schizophrenia treatment roluperidone by at least two…
To address the clinical deficiencies stated in the CRL, Minerva must provide additional safety and efficacy data for roluperidone…
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Complete Response letter
FDA rejection to delay Lebrikizumab chances to enter atopic dermatitis market: GlobalData
GlobalData currently expects Lilly to resubmit lebrikizumab’s BLA in Q4 2023
USFDA issues CRL for proposed biosimilar Insulin-R: Biocon
The US Food and Drug Administration (USFDA) issues a Complete Response Letter (CRL) to convey to a company that its initial review…
US FDA declines to approve two more China-tested drugs
The decisions could add pressure on Chinese stocks, especially biotech companies, at a time shares of several US-listed Chinese…
Lilly issues Complete Response Letter for Sintilimab in combination with Pemetrexed and Platinum…
The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form,…
Successive drug launches will drive growth of NASH market in seven major markets: GlobalData
The NASH market will undergo a very rapid growth, at a compound annual growth rate (CAGR) of 68.8 per cent from 2019 to 2029
Avenue Therapeutics receives complete response letter from the FDA for IV Tramadol
The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended…
US FDA denies approval to Mallinckrodt for Terlipressin to treat Hepatorenal Syndrome Type 1
The Complete Response Letter stated that, based on the available data, the agency cannot approve the terlipressin NDA in its…
US FDA denies approval for Tricida’s Veverimer
Veverimer (TRC101), a non-absorbed, orally-administered polymer, is designed to treat metabolic acidosis in patients with chronic…
USFDA issues response letter for new drug application for insulin glargine: Biocon
As per the USFDA, a Complete Response Letter (CRL) is sent to an applicant if the agency determines that it will not approve the…