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RSS FeedPosted by Michael Wonder on 10 Mar 2021
Developers of Russian Sputnik V vaccine doubt EU regulator's neutrality, want apology
9 March 2021 - The developers of Russia’s Sputnik V vaccine against COVID-19 on Tuesday questioned the EMA's neutrality, after ...
Posted by Michael Wonder on 09 Mar 2021
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-L201 gene therapy for leukocyte adhesion deficiency-I
9 March 2021 - Enrollment complete in Phase 1/2 clinical trial of RP-L201 for the treatment of LAD-I. ...
Posted by Michael Wonder on 09 Mar 2021
Seqirus announces U.S. FDA approval of expanded age indication of its cell based quadrivalent influenza vaccine for people two years of age and older
5 March 2021 - Seqirus today announced that the U.S. FDA has approved Flucelvax Quadrivalent (influenza vaccine), the company's cell-based quadrivalent ...
Posted by Michael Wonder on 09 Mar 2021
Biden’s silence on an FDA nominee underscores how tough it is to fill that job
9 March 2021 - Nearly everyone here expected President Biden to move with record speed to nominate someone to lead ...
Posted by Michael Wonder on 09 Mar 2021
Pandemic forces FDA to sharply curtail drug company inspections
9 March 2021 - The steep decline in oversight has stalled a number of new drug applications. ...
Posted by Michael Wonder on 09 Mar 2021
Acadia Pharmaceuticals provides regulatory update on supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis
8 March 2021 - Acadia Pharmaceuticals today announced that the Company received a notification from the U.S. FDA on 3 March ...
Posted by Michael Wonder on 09 Mar 2021
Roche receives FDA approval for Ventana ALK (D5F3) CDx assay to identify lung cancer patients eligible for targeted treatment with Lorbrena (lorlatinib)
9 March 2021 - The Ventana ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted ...
Posted by Michael Wonder on 09 Mar 2021
AltruBio’s neihulizumab granted fast track designation by the FDA for steroid refractory acute graft versus host disease
8 March 2021 - AltruBio announced today that the U.S. FDA granted fast track designation for its immune checkpoint regulator, ...
Posted by Michael Wonder on 09 Mar 2021
Sesen Bio submits marketing authorisation application to the European Medicines Agency for Vicineum
8 March 2021 - Potential approval in Europe anticipated in early 2022. ...
Posted by Michael Wonder on 08 Mar 2021
U.S. FDA grants fast track designation to three Passage Bio gene therapy candidates targeting rare CNS disorders
8 March 2021 - FDA designation will facilitate development and expedited review of company’s lead gene therapy product candidates for ...
Posted by Michael Wonder on 08 Mar 2021
Women report worse side effects after a COVID-19 vaccine
8 March 2021 - Men and women tend to respond differently to many kinds of vaccines. That’s probably because of a ...
Posted by Michael Wonder on 08 Mar 2021
Health Canada approves Keytruda (pembrolizumab) as first-line treatment for adults with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
8 March 2021 - Approval based on significant progression-free survival findings from Phase 3 KEYNOTE-177 trial. ...
Posted by Michael Wonder on 08 Mar 2021
Viatris and Kindeva Drug Delivery announce FDA tentative approval of the first abbreviated new drug application generic version of Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
8 March 2021 - Milestone reinforces Viatris' commitment to complex products and innovative solutions to help increase patient access ...
Posted by Michael Wonder on 08 Mar 2021
BioMarin announces FDA regenerative medicine advanced therapy designation granted to valoctocogene roxaparvovec, investigational gene therapy for haemophilia A
8 March 2021 - RMAT designation granted by FDA during bleeding disorders awareness month. ...
Posted by Michael Wonder on 08 Mar 2021
Genentech provides update on Tecentriq U.S. indication in prior-platinum treated metastatic bladder cancer
7 March 2021 - Genentech today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum ...