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RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 11 Jan 2023
Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection
10 January 2023 - The OncobiotaLUNG assay is the first blood microbiome driven liquid biopsy with proven effectiveness, including identifying cancer ...
Posted by Michael Wonder on 11 Jan 2023
EndoTheia announces FDA breakthrough device designation for technology to improve endoscopic surgery
10 January 2023 - EndoTheia announced today that it has gained priority status from the FDA by receiving a breakthrough ...
Posted by Michael Wonder on 10 Jan 2023
US Supreme Court rebuffs Pfizer plan to help patients pay for heart medication
9 January 2023 - The US Supreme Court on Monday turned away Pfizer's bid to revive its plan to cover ...
Posted by Michael Wonder on 10 Jan 2023
Pharmacy benefit managers and the Federal Trade Commission: a relationship gone sour
9 January 2023 - On 7 June 2022, the Federal Trade Commission announced its decision to launch an inquiry into the ...
Posted by Michael Wonder on 10 Jan 2023
Four types of bias in medical AI are running under the FDA’s radar
9 January 2023 - Although artificial intelligence is entering health care with great promise, clinical artificial intelligence tools are prone ...
Posted by Michael Wonder on 10 Jan 2023
Moderna considers price of $110-$130 for COVID-19 vaccine
9 January 2023 - Commercial price is similar to Pfizer’s plans for after government contracting ends. ...
Posted by Michael Wonder on 10 Jan 2023
Qulipta now approved by Health Canada for the preventive treatment of episodic migraine in adults
9 January 2023 - Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist (gepant) specifically developed for the ...
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
Opticyte earns FDA breakthrough device designation for the first cell O2 patient monitor for organ failure
9 January 2023 - Opticyte leverages proprietary machine learning to non-invasively assess organ dysfunction due to low cellular oxygenation in ...
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
JAMP Pharma Group receives Health Canada approval for JAMP Sitagliptin, a new generic alternative for the treatment of type 2 diabetes
6 January 2022 - The JAMP Pharma Group is pleased to announce the Health Canada approval of JAMP Sitagliptin, a generic ...
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 ...