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 ...
A cancer diagnosis is already devastating. It’s even more gut-wrenching when your doctor tells you that a drug shortage has ...
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 ...
The US Food and Drug Administration (FDA) has increased its collaboration with cancer drug manufacturers in a bid to overcome the country’s ongoing drug shortage problem and reduce impacts on patients ...
An advisory panel to the Food and Drug Administration unanimously voted against a diabetes implant from Intarcia Therapeutics — a former biotech unicorn that faltered after the FDA rejected said ...
A group of advisers to the Food and Drug Administration voted in favor of Alnylam Pharmaceuticals’ treatment for a debilitating heart disease Wednesday, but only after a day-long debate ...
The U.S. Food and Drug Administration (FDA) has approved the first drug in a family of medicines known as JAK inhibitors that can treat myelofibrosis patients with anemia. Momelotinib (Ojjaara) is ...
Iovance Biotherapeutics IOVA announced that the FDA has postponed the previously expected decision date, regarding the company’s biologics license application (BLA) for lifileucel, from Nov 25 ...
The Food and Drug Administration granted Merck a priority review for its application for Keytruda in combination with concurrent chemoradiotherapy, the company announced Wednesday. According to Merck, ...
(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 ...
A panel of medical advisers on Thursday unanimously dashed a Cambridge biotech’s hopes that US regulators would reconsider a twice-rejected implantable device designed for adults with ...
A cancer diagnosis is already devastating. It’s even more gut-wrenching when your doctor tells you that a drug shortage has disrupted your treatment regimen—that your hospital can’t get its ...
