Pharmaceutical

Sarepta’s disappointing data put the FDA in a difficult spot

Sarepta’s disappointing data put the FDA in a difficult...

Nov 1, 2023

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STAT+: Pharmalittle: Sarepta Duchenne therapy misses primary endpoint; FDA holds panel for first CRISPR treatment for sickle cell

STAT+: Pharmalittle: Sarepta Duchenne therapy misses pr...

Nov 1, 2023

Sarepta said its gene therapy for Duchenne muscular dystrophy failed to improve ...

FDA accepts Day One’s NDA for tovorafenib

FDA accepts Day One’s NDA for tovorafenib

Oct 31, 2023

The US Food and Drug Administration (FDA) has accepted Day One Biopharmaceutica...

Shorla acquires methotrexate solution from Therakind in the US

Shorla acquires methotrexate solution from Therakind in...

Oct 31, 2023

Shorla Oncology has acquired the oncology and autoimmune drug Jylamvo (methotre...

Phase I/II trial begins for SpyGlass intraocular drug delivery implant

Phase I/II trial begins for SpyGlass intraocular drug d...

Oct 31, 2023

SpyGlass Pharma is initiating Phase I/II clinical trials investigating its drug...

M&A market performance suffered in Q3 2023

M&A market performance suffered in Q3 2023

Oct 31, 2023

The third quarter of 2023 saw a slight fall in deal activity after the recovery ...

Aragen invests $30m in new biologics manufacturing facility in India

Aragen invests $30m in new biologics manufacturing faci...

Oct 31, 2023

Aragen Life Sciences has invested $30m to set up a new biologics manufactur...

Sellas presses ahead with fast track designation for lymphoma

Sellas presses ahead with fast track designation for ly...

Oct 31, 2023

The US Food and Drug Administration (FDA) has granted a fast track designation ...

Half of top 20 biopharma company market cap impacted amid the IRA in Q3 2023

Half of top 20 biopharma company market cap impacted am...

Oct 31, 2023

Leading biopharmaceutical companies are reshaping their strategies in light of ...

Sosei Heptares hits discovery milestone in GPCR deal with Genentech

Sosei Heptares hits discovery milestone in GPCR deal wi...

Oct 31, 2023

Sosei Heptares will receive $3.75m from Genentech after it reaches a discovery-...

Roche seeks label expansion for Elevidys amid missing Phase III endpoint

Roche seeks label expansion for Elevidys amid missing P...

Oct 31, 2023

Roche and Sarepta Therapeutics’ have announced top-line results from the Ph...

ArriVent’s lung cancer therapy gains FDA breakthrough therapy status

ArriVent’s lung cancer therapy gains FDA breakthrough t...

Oct 31, 2023

ArriVent Biopharma has received the US Food and Drug Administration's (FDA) bre...

On the eve of Halloween, the FDA weighs whether medicine should ever taste like candy

On the eve of Halloween, the FDA weighs whether medicin...

Oct 30, 2023

The rare moment of levity during the meeting on candy-like drugs came when a den...

STAT+: Sarepta’s Duchenne gene therapy fails to meet primary endpoint in pivotal trial

STAT+: Sarepta’s Duchenne gene therapy fails to meet pr...

Oct 30, 2023

Sarepta Therapeutics said Monday afternoon that its gene therapy for Duchenne mu...

In new order on AI, Biden is scrambling to catch up to emerging risks in health care

In new order on AI, Biden is scrambling to catch up to ...

Oct 30, 2023

President Biden ordered the nation’s leading health agencies on Monday to develo...

STAT+: Cassava pulled back the curtain on its Alzheimer’s study — and revealed insurmountable problems

STAT+: Cassava pulled back the curtain on its Alzheimer...

Oct 30, 2023

Cassava Sciences has long claimed its drug slows the cognitive decline of people...