FDA approves trial to advance treatment for Hereditary Spastic Paraplegia (HSP)
The trial will be conducted in the United States at Boston Children’s Hospital and will assess the safety, tolerability, and…
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US Food and Drug Administration
SPARC announces submission of IND application for SBO-154 to USFDA
SBO-154 set to enter global Phase 1 clinical trial for treatment of advanced solid tumours
Cipla recalls six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) due to container…
The company said that it is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number -…
Recent developments threaten COVID-19 vaccine demand and revenues: GlobalData
SAGE no longer recommends annual COVID-19 vaccine boosters for healthy adults under 60 years of age after they have received both…
Strides’ Bangalore facility gets EIR from USFDA
The company’s flagship facility was inspected by the USFDA between December 5 and 9, 2022, and a form 483 listing three…
Pfizer, BioNTech get US FDA nod for emergency use of COVID-19 vaccine in adolescents
This is the first COVID-19 vaccine authorised in the US for use in this age group
Inovio may move COVID-19 vaccine trial overseas after funding from US ends
Inovio said, depending on the results of its mid-stage trial, it would run the late-stage study for its vaccine candidate,…
Gilead gets US FDA Accelerated Approval for Trodelvy to treat metastatic urothelial cancer
New indication marks secondFDAapproval for Trodelvy in 2021
AstraZeneca to supply 500,000 additional doses of COVID-19 antibody cocktail to US
The drugmaker said the $205 million US extension for 500,000 antibody doses builds on a contract agreed with government agencies…
AbCellera gets EUA from US FDA for its antibody Bamlanivimab, along with Etesevimab for COVID-19
Lilly plans to manufacture more than 250,000 doses of the bamlanivimab and etesevimab therapy throughout Q1 2021, and up to a…