Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
Intas Pharmaceuticals has appointed Girish Bhunje as Senior Vice President – API Operations
This makes the company among few in India to offer fully integrated, end-to-end ADC drug substance development and manufacturing, encompassing payload synthesis, linker development and manufacturing
With this commissioning, Shilpa Medicare joins a very small group of Indian companies capable of offering end-to-end ADC Drug Substance development and manufacturing
The filing is backed by positive Phase 3 results recently published in JAMA Neurology
After a volatile decade in which approvals swung sharply from year to year, 2025’s total pushed past long-term norms, exceeding the 10-year average
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized
Country’s deep scientific talent pool and its growing role as a clinical trial destination makes it central to how Parexel serves sponsors
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