BMS gets EC approval for Opdivo combination to treat gastrointestinal cancers
The EC approval was based on results from the Phase 3 CheckMate-649 trial, which showed positive outcomes for…
Novartis to support manufacture of Pfizer-BioNTech Covid-19 vaccine
22 Oct 21The agreement extends Novartis’ earlier supply agreement for the fill and finish of more than 50 million doses…
US FDA authorises Moderna, J&J Covid-19 booster shots for emergency use
21 Oct 21The US FDA has also authorised the use of heterologous booster dose of Covid-19 vaccines, in addition to…
LumiraDx SARS-CoV-2 Antigen test granted emergency use approval in India
21 Oct 21LumiraDx claims that its microfluidic technology and point of care platform supports a wide range of tests with…
Sage Therapeutics, Biogen plan to seek FDA approval for depression drug zuranolone
20 Oct 21Zuranolone is an oral, once-daily, two-week therapy intended to treat major depressive disorder (MDD) and postpartum depression (PPD)
Dr. Reddy’s gets US FDA nod for generic version of Lenalidomide
20 Oct 21Lenalidomide is a generic version of Celgene’s Revlimid, intended to treat multiple myeloma (MM), myelodysplastic syndromes (MDS), and…
Gilead gets expanded FDA approval for low-dose Biktarvy to treat children with HIV
19 Oct 21Biktarvy is a once-daily dosing complete HIV-1 treatment comprising three medicines, with a limited drug interaction potential and…
Pfizer seeks Canada’s approval for Covid-19 vaccine for children aged five to 12 years
19 Oct 21The regulatory submission is based on data from the Phase 2/3 study of the Comirnaty 10μg dose in…
US FDA approves Roche’s Tecentriq as adjuvant treatment for early NSCLC
18 Oct 21The FDA approval is based on the Phase 3 IMpower010 study, which showed that adjuvant Tecentriq improved disease-free…
US FDA panel recommends J&J’s Covid-19 vaccine booster dose
18 Oct 21The recommendation is based on results from two clinical trials, including the Phase 3 ENSEMBLE 2 study, and…