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ENDPOINTS NEWS
1d
Chi­nese im­ports of com­mon can­cer drug run dry, FDA says
China’s Qilu Pharmaceutical has distributed all of the chemotherapy cisplatin that was imported as a result of the shortage ...
Atlanta Journal-Constitution24d
Cancer drug shortage prompts Georgia lawmakers to raise issue with FDA
The FDA subsequently allowed imports of the cancer drug from China, from Qilu Pharmaceutical, whose version of the drug is unapproved in the U.S. Georgia’s elected officials are asking the FDA ...
Medscape5d
New FDA Orphan Drugs
New FDA Orphan Drugs: CDX-110, ATryn, ISIS 333611 The FDA has granted orphan drug designation to CDX-110 for the treatment of glioblastoma multiforme, ATryn for the treatment of hereditary ...
TheStreet.com26d
FDA Raises Concerns About Cell Therapeutics' Cancer Drug
Ahead of a Feb. 10 advisory panel meeting, regulators say pivotal trial of pixantrone was too small; they also express concern about heart safety of drug. Ahead of a Feb. 10 advisory panel meeting ...
The Business Journals8d
Waltham-headquartered BioLineRx gets FDA approval for cancer drug
An Israeli company that has a U.S. headquarters in Waltham said Monday it has received approval for a new drug for blood cancer. Biopharmaceutical company BioLineRx Ltd. (Nasdaq: BLRX) said the U ...
TheStreet.com2d
FDA Bans Some Japanese Food Imports
FDA is banning the import of some produce and dairy products from areas surrounding the Fukushima Daiichi nuclear plant affected by the March 11 earthquake and tsunami. FDA is banning the import ...
MedCity News22d
BMS Cancer Drug’s New FDA Nod Puts It on Path to Reach Blockbuster Status
A Bristol Myers drug that treats anemia caused by a type of blood cancer now has an FDA approval that moves it up in the hierarchy of treatments, expanding the eligible patient population and ...
New York Post27d
The FDA is now fast-tracking new drug approvals — why that’s so worrying
The Food and Drug Administration is now regularly approving new drugs after just one or two clinical trials — a significant departure from the more rigorous vetting process the agency was ...
The Business Journals8d
Publicly traded biotech firm BioLineRx gets FDA approval for cancer drug with help from Washington University
An Israeli company developing treatments for cancers and rare disease said Monday it has received approval for a new drug after completing clinical trials in partnership with Washington University.
Reuters1mon
US FDA puts Gilead Sciences blood cancer drug studies on hold
Aug 21 (Reuters) - Gilead Sciences (GILD.O) said on Monday the U.S. health regulator placed a clinical hold on studies of its blood cancer drug, just a month after the company scrapped a late ...
Mena FN10d
Biosyngen Received Fda Approval For Phase I/Ii Clinical Trials For Brl03, Targeting Lung Cancer, Gastric Cancer And Other Advanced Solid Tumors
(MENAFN- PR Newswire) SINGAPORE, Sept. 11, 2023 /PRNewswire/ -- On September 9th, 2023, Biosyngen Pte Ltd (hereafter as "Biosyngen") announced that the U.S. FDA has cleared the Investigational New ...
Medscape2d
New FDA Orphan Drugs
FDA Approves Clobazam Add-On for Lennox Syndrome The benzodiazepine is already available in 100 other countries, marketed under different brand names. News, October 24, 2011 Orphan Drug Status for ...

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