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U.S. Food and Drug Administration
... in the field. The approval process for drugs from the US Food and Drug Administration involves lengthy clinical trials, which usually take around 12 years—meaning ...
... plans to include the data in an application for marketing authorization by FDA. SECTION 1 HELIUS MEDICAL TECHNOLOGIES ACTIVITIES Helius Medical Technologies Inc is engaged ...
... brands, the company backs bill introduced bySenators Feinstein and Collins calling for FDA authority to regulate safety of beauty products Counter Brands, LLC. - parent ...
... (sNDA) based on data from the CANVAS Program was filed with the FDA on October 2, 2017. WHAT IS INVOKANA®?INVOKANA® (canagliflozin) is a prescription medicine ...
... FDA approves first telehealth option to program cochlear implants remotely ...
... Arlluk Technology Solutions, LLC awarded a $19M contract with the Food and Drug Administration (FDA) to provide a Container as a Service (CaaS) Solution ...
... ramifications for patients both on the island and throughout the U.S. The FDA has been working closely with federal and Puerto Rican authorities to help ...
... multiple sectors of healthcare, announced today that the Food and Drug Administration (FDA) issued numerous Final and Draft Guidance documents. Among them was the final ...
... 38.53. On November 09th, 2017, Dynavax Technologies announced that the US Food and Drug Administration has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention ...
... were called into question on May 17, 2017, when the U.S. Food and Drug Administration ("FDA") warned the public that Magellan's lead tests may provide ...
... and supplement the clinical position and initiate clinical studies for defining an FDA regulatory pathway Define and clarify the dietary supplement introduction and positioning for ...
... plans to include the data in an application for marketing authorization by FDA. Registrational Trial Data Patients in both Groups were Significantly Clinically Better at ...
... Lu 177 dotatate* (Lutathera®) New Drug Application (NDA) to the US Food and Drug Administration (FDA) FDA allowed an amendment to the protocol for the ...
... a specialty pharmaceutical company, today announced the U.S. Food and Drug Administration ("FDA") has extended the review period for the New Drug Application ("NDA") for ...
... up by the new breed of immuno-oncology drugs. Despite misgivings by an FDA advisory panel, the FDA Thursday approved Sutent to treat adult patients who ...
... The FDA has created a policy framework for cellular therapies and other regenerative medicines ...
... to be used more quickly. The move prompted a tough response from FDA Commissioner Scott Gottlieb, M.D., however, who argued that it could leave military ...
... a burgeoning medical field that previously has received little oversight. The Food and Drug Administration laid out a strategy for regulating cell-based medicine, including hundreds ...
... also protecting patients from dangerous products, the U.S. Food and Drug Administration (FDA) on Wednesday issued guidelines for exempting certain cell and tissue treatments from ...
... Led by ex-FDA official Peggy Berry, ComplianceOnline’s popular seminar on “eCTD Submissions of IND and ...
... clearance for BHV-0223 in Amyotrophic Lateral Sclerosis (ALS)-In October, the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with its clinical program ...
... were observed. The Corporation secured a Rare Pediatric Disease Designation by the FDA for RyplazimTM, a plasminogen replacement therapy for the treatment of patients with ...
... the stuff of science fiction,'' said Scott Gottlieb, the commissioner of the F.D.A., ''but rather, real-life science where cells and tissues can be engineered to ...
... products directly to patients. "The promise of this technology is why the FDA is so committed to encouraging and supporting innovation in this field," agency ...
... list price for Spark Therapeutics’ gene therapy Luxturna--which recently received a unanimous FDA advisory committee recommendation to treat a rare, inherited form of blindness, considerably ...
... list price for Spark Therapeutics’ gene therapy Luxturna--which recently received a unanimous FDA advisory committee recommendation to treat a rare, inherited form of blindness, considerably ...
... Enlarge this image The Food and Drug Administration says codeine painkillers shouldn't be given to children under age ...
... the battlefield under a legislative compromise passed by Congress. But the Food and Drug Administration would remain the only federal agency capable of approving new ...
... patients have hemophilia A and about one-third of those develop resistance. The FDA gave expedited approval to Hemlibra, also known as emicizumab, for adults and ...
... Alnylam has kicked off a rolling FDA filing for its RNAi drug patisiran. The gene silencing pioneer expects to ...
... Patients As of November 6, 2017, Cellectis announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September ...
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