Industry experts respond to FDA move to streamline biosimilar development
The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with…
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
FDA
FDA’s curb on overseas cell processing to hit smaller cell and gene therapy companies:…
Regulators haven’t specified how many trials are affected, though therapies like CAR-T, which sometimes use overseas manufacturing…
FDA discontinue rare pediatric disease designation program despite increase in RPD approvals
Due to concerns over its effectiveness, the US Congress did not renew the RPDD program and began to close it in late 2024
Entvin AI raises $500K in Y combinator funding to streamline FDA drug approval process
Entvin AI, founded by IIT Bombay graduates, launches its AI platform to optimise regulatory compliance for pharmaceutical…
FDA proposes removal of oral Phenylephrine from OTC nasal decongestant products
Agency cites lack of effectiveness as basis for proposed change, allowing continued sales pending final order
Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector
The author explains how continuous manufacturing is reshaping pharmaceutical production
FDA issues warning letters to two Chinese firms over data integrity concerns
Agency flags nonclinical testing data and animal care violations, review ongoing
Alembic gains USFDA final approval for Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg
Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg have an estimated market size of $ 21 million for twelve months ending June 2024…
FDA approves gene therapy to treat adults with Metastatic Synovial Sarcoma
Among the 44 patients in the trial who received Tecelra, the overall response rate was 43.2 per cent and the median duration of…
FDA approves Guardant Health’s Shield blood test as first primary CRC screening option
Shield is first blood test approved by FDA as a primary screening option for colorectal cancer and that meets performance…