# accelerated approval (news sources) — RSS Amplifier

Recent posts from the 1 feeds in the RSS Amplifier directory that cover accelerated approval.

Page: <https://rssamplifier.com/topics/accelerated-approval/news>  
Feed: <https://rssamplifier.com/topics/accelerated-approval/news.md>

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## [Roche commits $750m to double Oregon-based US manufacturing capacity](https://www.pharmaceutical-technology.com/news/roche-750m-oregon-us-injectable-manufacturing-site/)

_2026-08-21 · Annabel Kartal Allen · Pharmaceutical Technology_

Roche's Oregon fill-finish site will produce both autoinjectors and pre-filled syringes – serving its pipeline and portfolio.

## [Eli Lilly’s weekly insulin jab Onswik set for NHS use if approved](https://www.pharmaceutical-technology.com/news/eli-lillys-weekly-insulin-jab-onswik-set-for-nhs-use-if-approved/)

_2026-08-21 · Robert Barrie · Pharmaceutical Technology_

Lilly’s drug could cut the number of injections each patient needs by 85%.

## [WellSpan and Johns Hopkins renew partnership for advanced cancer care access](https://www.pharmaceutical-technology.com/news/wellspan-johns-hopkins-advanced-cancer-care/)

_2026-08-21 · Salong Debbarma · Pharmaceutical Technology_

WellSpan Health and Johns Hopkins Medicine have renewed their oncology collaboration to widen access to advanced care throughout central Pennsylvania, US.

## [Charles River and MVC to develop enterovirus vaccine](https://www.pharmaceutical-technology.com/news/charles-river-mvc-enterovirus-vaccine/)

_2026-08-21 · Salong Debbarma · Pharmaceutical Technology_

Charles River Laboratories International and MVC have entered a collaboration to support the characterisation, along with validation of the virus seed bank for the latter’s next-generation multivalent enterovirus vaccine.

## [Regeneron’s Pasatru wins FDA approval in ultra-rare ‘stone man disease’](https://www.pharmaceutical-technology.com/news/regenerons-pasatru-wins-fda-approval-in-ultra-rare-stone-man-disease/)

_2026-08-20 · Robert Barrie · Pharmaceutical Technology_

Pasatru demonstrated strong efficacy in a Phase III trial, helping patients reduce lesions and flare-ups.

## [Kynexis pockets €97m to advance cognition-focused schizophrenia drug](https://www.pharmaceutical-technology.com/news/kynexis-97m-cognitive-focused-schizophrenia-drug-progression/)

_2026-08-20 · Annabel Kartal Allen · Pharmaceutical Technology_

Kynexis will now prepare for registrational studies on lead asset, KYN-5356 in cognitive impairment associated with schizophrenia (CIAS).

## [FDA grants accelerated approval to Ultragenyx’s Genglycos gene therapy](https://www.pharmaceutical-technology.com/news/fda-approval-ultragenyx-genglycos-gene-therapy/)

_2026-08-20 · Salong Debbarma · Pharmaceutical Technology_

Ultragenyx Pharmaceutical has received accelerated approval from the FDA for its gene therapy, Genglycos, to treat GSDIa.

## [SandboxAQ introduces AQPotency for virtual drug screening](https://www.pharmaceutical-technology.com/news/sandboxaq-aqpotency-virtual-drug-screening/)

_2026-08-20 · Salong Debbarma · Pharmaceutical Technology_

SandboxAQ has introduced AQPotency, a LQM designed to virtually screen and predict the potential of drug candidates without the need for a solved protein structure.

## [BioMarin spends up to $490m for Alesta’s bone disease candidate](https://www.pharmaceutical-technology.com/news/biomarin-spends-up-to-490m-for-alestas-bone-disease-candidate/)

_2026-08-19 · Robert Barrie · Pharmaceutical Technology_

The deal provides BioMarin with a potential rival to AstraZeneca’s blockbuster Strensiq in hypophosphatasia.

## [Trump expected to nominate Heidi Overton as new FDA commissioner](https://www.pharmaceutical-technology.com/news/trump-nominates-heidi-overton-fda-commissioner/)

_2026-08-19 · Annabel Kartal Allen · Pharmaceutical Technology_

Overton could take the helm at the FDA during a tumultuous period for the agency, defined by several resignations, firings and redundancies.

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_2026-08-19 · **Sponsored**_

Read AI summaries and listen to concise audio briefings for the latest stories.

## [Andelyn Biosciences to develop GM2 gangliosidosis therapy](https://www.pharmaceutical-technology.com/news/andelyn-to-develop-gm2-gangliosidosis-therapy/)

_2026-08-19 · Salong Debbarma · Pharmaceutical Technology_

Andelyn Biosciences is set to develop and manufacture a gene therapy known as AAV9-GM2, for Queen’s University to treat GM2 gangliosidoses, including Tay-Sachs and Sandhoff diseases.

## [BeOne Medicines and partners renew Brukinsa access programme for CLL](https://www.pharmaceutical-technology.com/news/beone-medicines-partners-renew-brukinsa-programme/)

_2026-08-19 · Salong Debbarma · Pharmaceutical Technology_

BeOne Medicines, the BeOne Care Foundation, and The Max Foundation have extended their Brukinsa access programme for CLL until 2028.

## [Reformed pharmaceutical regulation across India’s drug landscape](https://www.pharmaceutical-technology.com/analyst-comment/reformed-pharmaceutical-regulation-across-india-drug-landscape/)

_2026-08-18 · GlobalData Healthcare · Pharmaceutical Technology_

One of the major changes made to India’s primary legal framework for drug price regulation affects the pricing of essential drugs.

## [Updated UK guidance for finerenone introduces new treatment for HF patients](https://www.pharmaceutical-technology.com/analyst-comment/updated-uk-guidance-finerenone-hf/)

_2026-08-18 · GlobalData Healthcare · Pharmaceutical Technology_

New guidance from NICE provide a framework for UK care providers using finerenone to manage the treatment of certain types of heart failure.

