Tuesday, December 1, 2020

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U.S. Food and Drug Administration (FDA) approved Regenerative Medicine Advanced Therapy (RMAT) designation from the for ADP-A2M4 for the treatment of synovial...

Dec. 03, 2019: U.S. Food and Drug Administration (FDA) approved Adaptimmune Therapeutic’s  Regenerative Medicine Advanced Therapy (RMAT) designation for ADP-A2M4 for the treatment...

Immunomedics Resubmits Biologics License Application to FDA for the treatment of metastatic triple-negative breast cancer (mTNBC)

Dec. 03, 2019: Immunomedics,a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC) announced the resubmission of its Biologics License Application...

The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial of ATRC-101...

Dec. 03, 2019:The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b...

OSE Immunotherapeutics Announces Positive Results from first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial of Anti-IL-7 Receptor Antagonist OSE-127

Dec 02, 2019: OSE Immunotherapeutics  announced completion and positive results from the Phase 1 study of OSE-127, a humanized monoclonal antibody with...

AstraZeneca divests rights Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the US and Canada to Cheplapharm Arzneimittel GmbH...

Dec. 03, 2019: AstraZeneca has agreed to put up for sale the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended...

Co-Diagnostics Gets “Indian FDA” Approval for Infectious Disease Testing (in vitro diagnostic assays)in One of the World’s Biggest Markets

Dec. 03, 2019: Co-Diagnostics  Inc. announced that Indian regulators have approved five in vitro diagnostic assays to be manufactured and sold by CoSara Diagnostics...

The History of clinical research

The evolution of clinical research traverses a long and mesmerizing journey. From the first recorded trial of legumes in biblical times to...

FDA approved Pivotal Phase III Trial Design of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA)

Dec. 02, 2019: Akari Therapeutics announced the design of a pivotal Phase III pediatric trial in HSCT-TMA following a FDA End-of-Phase II...

The U.S. Food and Drug Administration (FDA) approved Medical devices (pacemakers and defibrillators)That Help Keep the Heart Beating

Dec. 02, 2019: The U.S. Food and Drug Administration (FDA) approved Medical devices such as pacemakers and defibrillators that have extended and...

Merck’s Ebola Vaccine (Ervebo) Approved in Europe by the European Commission

Dec. 03, 2019: Merck with its Researchers, healthcare providers and global health officials finally breathe a sigh of relief after the hardwork...

Aquestive Therapeutic’s Libervan (diazepam) Buccal Film Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for the Management...

Dec. 02, 2019:  Aquestive Therapeutics, Inc. announced the completion, as planned, of the rolling submission of a New Drug Application (NDA) to the U.S....

FDA approved Innovent Biologic’s Acceptance of NDA submission for Pemigatinib(FGFR1/2/3 inhibitor) in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with...

Dec 02, 2019:  Innovent Biologics, Inc. announced that Incyte submit the new drug application (NDA)  to the U.S. Food and Drug Administration (FDA) for...

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Eisai and Wren Therapeutics Enter Into Research Collaboration Agreement for Drug Discovery for Synucleinopathies

November 30, 2020: Eisai and Wren Therapeutics announced that the companies have entered into an exclusive research collaboration agreement aiming to advance...

AstraZeneca agreed to sell rights to Crestor to be divested to Grünenthal in Europe

December 01, 2020: AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the...

AstraZeneca’sForxiga approved in Japan for chronic heart failure

November 30, 2020: AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving...

Moderna Announces the EC Approval for Initial 80 Million Doses of mRNA Vaccine Against COVID-19

November 25, 2020: "Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines...