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The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract

FDA rejection of Spero’s tebipenem ‘raises resistance threat’

https://pharmaphorum.com/news/fda-rejection-of-speros-tebipenem-raises-resistance-threat/

Market Access/ News/ News/ News/ R&D

US panel backs Omicron-targeting vaccines for booster campaigns

Phil Taylor BioNTech, coronavirus, COVID-19, COVID-19 vaccine, fda, GlaxoSmithKline, Moderna, Novavax, Omicron, Pfizer, regulatory, variant 0 Comment

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according

US panel backs Omicron-targeting vaccines for booster campaigns

https://pharmaphorum.com/news/us-panel-backs-omicron-targeting-vaccines-for-booster-campaigns/

Market Access/ Views & Analysis/ Views and analysis

How the US’s pending PIE Act will improve patient access to medication

Jessica Hagen AMCP, fda, Jennifer Mathieu, patient access 0 Comment

Jennifer Mathieu, vice president of policy and government relations at the Academy of Managed Care Pharmacy (AMCP), tells

How the US’s pending PIE Act will improve patient access to medication

https://pharmaphorum.com/market-access-2/how-uss-pending-pie-act-will-improve-patient-access-medication/

News/ News/ R&D

Sarepta shares yo-yo as FDA places hold on Duchenne trial

Phil Taylor Duchenne muscular dystrophy, Exondys 51, fda, rare disease, regulatory, safety, Sarepta, vesleteplirsen 0 Comment

Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of

Sarepta shares yo-yo as FDA places hold on Duchenne trial

https://pharmaphorum.com/news/sarepta-shares-yo-yo-as-fda-places-hold-on-duchenne-trial/

Market Access/ Views & Analysis/ Views and analysis

US frets over pharma supply chain security

Ben Hargreaves biologics, China, fda, pharma, US 0 Comment

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and

US frets over pharma supply chain security

https://pharmaphorum.com/market-access-2/us-frets-over-pharma-supply-chain-security/

Market Access/ News/ News

FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis

Phil Taylor Acadia Pharmaceuticals, Alzheimer's disease, fda, Nuplazid, psychosis 0 Comment

Acadia Pharma’s attempts to extend the indications of its Nuplazid drug in the US to include Alzheimer’s disease-related

FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis

https://pharmaphorum.com/news/fda-panel-turns-down-acadias-nuplazid-for-alzheimers-psychosis/

Market Access/ Views & Analysis/ Views and analysis

Six months after authorization, what do we know about Paxlovid?

mike.hammerton@pharmaphorum.com COVID-19, fda, Paxlovid, Pfizer 0 Comment

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment

Six months after authorization, what do we know about Paxlovid?

https://pharmaphorum.com/market-access-2/six-months-after-authorization-what-do-we-know-about-paxlovid/

Market Access/ R&D/ Views & Analysis/ Views & Analysis/ Views and analysis

FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

Ben Hargreaves biologic medicines, China, fda, Lilly 0 Comment

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates

FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

https://pharmaphorum.com/market-access-2/fdas-treatment-of-china-developed-drugs-spurs-demands/

Market Access/ News/ News

Second unanimous FDA adcomm vote boosts bluebird bio

Phil Taylor beta thalassaemia, bluebird bio, fda, gene therapy, rare disease, regulatory 0 Comment

bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene

Second unanimous FDA adcomm vote boosts bluebird bio

https://pharmaphorum.com/news/second-unanimous-fda-adcomm-vote-boosts-bluebird-bio/

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