Drug Approval | 08 July 2022
Lupin’s Somerset manufacturing plant Receives EIR from US FDA
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
The vaccine is under FDA review
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk
This multicenter, open-label Phase I study is designed to assess the safety and tolerability
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
Lacosamide Injection is used to treat partial-onset seizures.
It is a two dose vaccine to be administered intramuscularly at 28 days apart
Safety in these pediatric populations was consistent with the known safety profile across approved adult and pediatric indications1,2
First and only PARP inhibitor to improve invasive disease-free survival in patients
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally
ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.
It´s the first trial to demonstrate the benefits of dual pathway inhibition
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
Alopecia areata usually presents as a few small bald patches in the head
Acceptance based on results from the phase 3 KEYNOTE-091 trial
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