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RSS FeedPosted by Michael Wonder on 12 Jan 2023
Eton Pharmaceuticals announces FDA acceptance of NDA response for dehydrated alcohol injection
11 January 2023 - Application assigned a PDUFA date of 27 June 2023. ...
Posted by Michael Wonder on 12 Jan 2023
Eisai submits marketing authorisation application for lecanemab as treatment for early Alzheimer's disease in Europe
11 January 2023 - Eisai and Biogen announced today that Eisai has submitted a marketing authorisation application for lecanemab, an investigational ...
Posted by Michael Wonder on 09 Jan 2023
US FDA issues a CRL for the biologics license application for insulin-R
7 January 2023 - The US FDA has issued a complete response letter for the biologics license application for the insulin-R ...
Posted by Michael Wonder on 09 Jan 2023
Krystal Biotech announces FDA’s 3 month extension of BLA PDUFA date and regulatory update for B-VEC to treat patients with dystrophic epidermolysis bullosa
9 January 2023 - Krystal Biotech today announced that on 5 January 2023, the US FDA notified the Company that ...
Posted by Michael Wonder on 09 Jan 2023
Santhera and ReveraGen announce FDA acceptance of new drug application for vamorolone in Duchenne muscular dystrophy
9 January 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce that the US FDA has accepted the new drug application for ...
Posted by Michael Wonder on 08 Jan 2023
Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia
7 January 2023 - The FDA target date (PDUFA date) for completion of the review is 10 May 2023. ...
Posted by Michael Wonder on 07 Jan 2023
Eisai submits supplemental biologics license application to FDA for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease
7 January 2023 - Submission for traditional approval follows FDA accelerated approval of Leqembi on the same day, and is ...
Posted by Michael Wonder on 07 Jan 2023
Novan submits new drug application to the US FDA for berdazimer (SB206) 10.3% topical gel for the treatment of molluscum contagiosum
6 January 2023 - Potential FDA approval anticipated in first quarter 2024, assuming the filing is accepted by the FDA and ...
Posted by Michael Wonder on 07 Jan 2023
FDA grants priority review to Genentech’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
5 January 2023 - Results from the pivotal Phase 1/2 NP30179 study showed glofitamab induced durable response rates in people with ...
Posted by Michael Wonder on 07 Jan 2023
US FDA accepts for priority review the supplemental biologics license application for Pfizer’s 20 valent pneumococcal conjugate vaccine in infants and children
6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 05 Jan 2023
Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
5 January 2023 - Submission supported by comprehensive clinical trial programme, which demonstrated protection against RSV disease through the RSV ...
Posted by Michael Wonder on 05 Jan 2023
Checkpoint Therapeutics submits biologics license application to FDA for cosibelimab as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma
4 January 2023 - Positive and clinically meaningful pivotal clinical results announced in 2022 in both metastatic and locally advanced indications. ...
Posted by Michael Wonder on 04 Jan 2023
Enhertu type II variation application validated by EMA for the treatment of HER2 mutant metastatic non-small-cell lung cancer
4 January 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 Phase 2 trial results which showed Daiichi Sankyo and AstraZeneca’s Enhertu ...
Posted by Michael Wonder on 04 Jan 2023
Orasis Pharmaceuticals submits new drug application for investigational novel eye drop candidate, CSF-1, for the treatment of presbyopia
3 January 2023 - Phase 3 NEAR-1 and NEAR-2 clinical trials, involving over 600 patients, met primary and key secondary ...