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RSS FeedPosted by Michael Wonder on 03 May 2021
Intra-Cellular Therapies announces FDA acceptance of Caplyta (lumateperone) sNDAs for the treatment of bipolar depression
3 May 2021 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its supplemental new drug applications ...
Posted by Michael Wonder on 03 May 2021
How the FDA’s ‘master plan’ will affect NIH funding for digital medicine projects
3 May 2021 - The term B.C. took on a new meaning — Before COVID — last year when almost ...
Posted by Michael Wonder on 03 May 2021
Hutchmed completes rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
3 May 2021 - First NDA submission by Hutchmed in the U.S.; product launch preparations underway. ...
Posted by Michael Wonder on 03 May 2021
ALS groups to the FDA and drug sponsors: ‘We won’t be played again’
30 April 2021 - Working to improve the fight for therapies for amyotrophic lateral sclerosis (ALS, also known as Lou ...
Posted by Michael Wonder on 03 May 2021
Chiesi Global Rare Diseases announces FDA approval of Ferriprox (deferiprone) for treatment of transfusional iron overload due to sickle cell disease
1 May 2021 - Approval is based on demonstrated reduction in liver iron concentration. ...
Posted by Michael Wonder on 03 May 2021
FDA scraps another last-minute Trump-era policy
30 April 2021 - The US FDA on Friday revoked a policy issued in the final days of the Trump ...
Posted by Michael Wonder on 30 Apr 2021
FDA approves higher dosage of naloxone nasal spray to treat opioid overdose
30 April 2021 - The U.S. FDA announced today the approval of a higher dose naloxone hydrochloride nasal spray product to ...
Posted by Michael Wonder on 30 Apr 2021
FDA approves treatment for chronic kidney disease
30 April 2021 - Approval is first to cover many causes of disease. ...
Posted by Michael Wonder on 30 Apr 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
30 April 2021 - Application based on Phase 3 CheckMate-274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo. ...
Posted by Michael Wonder on 30 Apr 2021
Update on U.S. FDA review of LEO Pharma’s biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis
29 April 2021 - FDA has requested additional data relating to a device component of tralokinumab. ...
Posted by Michael Wonder on 30 Apr 2021
Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication
29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S ...
Posted by Michael Wonder on 30 Apr 2021
AstraZeneca struggles with data needed for COVID-19 vaccine’s approval
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...
Posted by Michael Wonder on 30 Apr 2021
Cerapedics announces FDA breakthrough device designation granted for P-15L bone graft for the treatment of degenerative disc disease
29 April 2021 - P-15L bone graft is currently being studied in the Company's ASPIRE IDE clinical trial. ...
Posted by Michael Wonder on 29 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for previously untreated metastatic bladder cancer
28 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favour of ...
Posted by Michael Wonder on 29 Apr 2021
Biogen provides regulatory update on the supplemental biologic license application for subcutaneous administration of Tysabri (natalizumab)
28 April 2021 - Biogen today announced that it has received a complete response letter from the U.S. FDA for ...