Monday, January 18, 2021

LATEST ARTICLES

Lets learn how can You summarize any Story/ article or Research Paper

What is summarizing: Giving a short statement of the important points by removing all extra fat. Why is it important: It allows...

Drug Approval process-FDA

The scope of this blog to give the overview of Drug approval process in US.

U.S. FDA approved priority review to sNDA for Braftovi® (encorafenib) in combination with erbitux® (cetuximab) (braftovi doublet) for the treatment of Brafv600e-mutant metastatic colorectal...

Dec 18, 2019: Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved priority review to the Company’s supplemental...

Galapagos in collaboration with Gilead submits NDA to U.S. Food and Drug Administration under priority review for filgotinib for rheumatoid arthritis treatment

Dec 19, 2019: Galapagos NV  announced that its collaboration partner, Gilead Sciences,) has submitted a New Drug Application (NDA) to the U.S....

Oxidien Pharmaceuticals Announces encouraging Response from FDA on Proposed Development Plan

Dec 19, 2019: Oxidien Pharmaceuticals, announced that it has received encouraging responses from U.S. Food and Drug Administration (FDA) regarding their proposed...

Bristol-Myers Squibb Announces Submission of Biologics License Application to the U.S. Food and Drug Administration (FDA) for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

Dec 18, 2019: Bristol-Myers Squibb Company announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration...

FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for the treatment of locally Advanced or Metastatic Urothelial Cancer

Dec 18, 2019: Seattle Genetics and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to...

Novartis provides update on (fevipiprant) LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma

Dec 16, 2019: Novartis announced topline results from its pivotal global Phase III LUSTER-1and LUSTER-2 studies examing the efficacy and safety of the...

Roche concludes getting hold of Spark Therapeutics, Inc. to reinforce presence in gene therapy

Dec 17, 2019: Roche and Spark Therapeutics, Inc. announced the completion of the acquisition following the receipt of regulatory approval from all...

Enzalutamide Approved by FDA for metastatic castration-sensitive prostate cancer (mCSPC) Treatment

Dec 17, 2019: Pfizer Inc. and Astellas Pharma Inc.recieves the FDA approved (first and only oral treatment) supplemental new drug application for...

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

Dec 17, 2019: AstraZeneca and MSD announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7...

Takeda collaborates with MiTest Health to Launch Innovative Disease Risk Prediction Tool to Redefine Crohn’s Disease Management

Dec 14, 2019: Takeda and MiTest Health LLC a pioneering health technology company, announced an exclusive partnership to optimize MiTest’s personalized risk...

Other

What Is a Blockbuster Drug?

What Is a Blockbuster Drug? "Blockbuster drugs are those that generate at least $1 billion of revenue per...

Covaxin: Everything that you should know

Covaxin is an investigational vaccine candidate for COVID19. It is in Phase III clinical trial as of today (20-Dec-2020). It is being...

Interview with Kashish Gupta: NIPER 2020, AIR-36

NIPER is a well renowned institute that offers Master's degree after qualifying GPAT (Graduate Pharmacy Aptitude Test) and NIPER entrance test. NIPER...