Blog
RSS FeedPosted 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 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
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 ...
Posted by Michael Wonder on 08 Mar 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and priority review of NDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
8 March 2021 - FDA has set Prescription Drug User Fee Act target action date of 23 August 2021. ...
Posted by Michael Wonder on 06 Mar 2021
U.S. FDA approves Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...
Posted by Michael Wonder on 06 Mar 2021
Genentech’s Actemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis associated interstitial lung disease, a rare, debilitating condition
4 March 2021 - The U.S. FDA previously granted priority review designation to Actemra for the treatment of systemic sclerosis-associated ...
Posted by Michael Wonder on 04 Mar 2021
Junshi Biosciences and Coherus BioSciences announce initiation of rolling submission of BLA for toripalimab to the U.S. FDA for the treatment of nasopharyngeal carcinoma
3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...
Posted by Michael Wonder on 04 Mar 2021
FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint
2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...
Posted by Michael Wonder on 04 Mar 2021
FDA releases a new plan to bring its data skills up to speed
4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...