News – Page 456 – Endpoints News

Updated: After long and winding road, FDA approves Amylyx's ALS drug in victory for patients and advocacy groups

3 years ago

FDA's advanced therapies office provides more clarity on gene therapy CMC considerations

3 years ago

CMS spent more than $18B in four years on accelerated approvals with incomplete confirmatory trials, inspector ...

3 years ago

Someone old, someone new: Moderna promotes CTO, raids Novartis for replacement amid pipeline push

3 years ago

Sanofi, Regeneron’s Dupixent scores another indication with first-ever approval for nodular skin disorder

3 years ago

Senate passes bill to rework animal testing requirements for drug developers

3 years ago

Patient report finds constipation condition not well-managed, opening door for better education from pharma

3 years ago

Cell and gene therapies from academia: EMA to help 5 projects going after unmet clinical needs

3 years ago

Gilead names 'kingpins' in counterfeit HIV med lawsuit

3 years ago

Vor Bio opts to keep manufacturing operations in-house for developing stem cell, CAR-T therapies

3 years ago

Aiming for fourth nod, Sarepta files another DMD gene therapy to FDA; Axsome headed toward migraine resubmission

3 years ago

Siga nabs $10.7M from the US government in deal for its monkeypox antiviral

3 years ago

As Amylyx decision waits in the wings, Biohaven’s ALS drug sinks (again) in platform trial

3 years ago

Almirall partners up with Simcere in potential $500M+ deal — with plans to take IL-2 candidate global

3 years ago

Manufacturing roundup: Aceto rebrands to Actylis; WuXi STA opens another facility

3 years ago

Tarsus looks to raise awareness of eyelid mite disease in campaign aimed at eyecare specialists

3 years ago

Aligos co-founders shoot back at J&J IP complaint with one of their own alleging fraud

3 years ago

Axcella touts interim NASH data but needs cash to stay afloat for 2024 topline readout

3 years ago

As lead drug flopped and AbbVie collab dissolved, cancer biotech resorts to buying rare disease company

3 years ago

Novo Nordisk joins Novartis, Roche in NLRP3 arena, betting $70M cash on NASH, cardiometabolic uses

3 years ago

I’m headed to London soon for #EUBIO22. Care to join me?

3 years ago

Another Avastin biosimilar joins the party as Roche's grip on the market loosens

3 years ago

SFJ plays hardball, demands rights to PhaseBio's lead candidate

3 years ago

As winter approaches, a European generics group raises alarm over energy prices for manufacturers

3 years ago

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