‘Weak' evidence and ‘unpleasant’ odor: Inside 200 FDA rejections

Today’s Big News

Jul 11, 2025

FDA rejects Capricor’s DMD cell therapy, asks for more data


Karyopharm lays off more workers as hunt for strategic alternatives turns up short


‘Weak' evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process


Chutes & Ladders—Pfizer’s longtime reputation wrangler plans departure 


Biopharma layoffs aren't letting up


Non-opioid pain drugmaker Pacira lays off 71 in California, retires facility in manufacturing upgrade


State AGs unveil opioid settlements totaling $720M with 8 drugmakers 

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

FDA rejects Capricor’s DMD cell therapy, asks for more data

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy cell therapy, raising questions about whether the agency's new leadership may be rowing back from some of the flexibility shown by the old regime. Capricor’s share price fell 38% to $7.11 in premarket trading.
 

Top Stories

Karyopharm lays off more workers as hunt for strategic alternatives turns up short

Karyopharm Therapeutics is laying off 20% of staffers as efforts to secure a strategic alternative have turned up short.

‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

Although many of the complete response letters uploaded by the FDA this week have been subtly disclosed in drug approval packages over the years, the consolidation of the rejection notices offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market.

SAP, Answerthink Help Emerging Biopharma Firms Scale With Confidence

Leaders discuss how built-in best practices and automation streamline growth for lean life sciences teams

Chutes & Ladders—Pfizer’s longtime reputation wrangler plans departure

Sally Susman, the communications chief who has shepherded Pfizer’s reputation and branding for more than 18 years, is departing the pharma giant at the end of the year amid its ongoing cost-cutting efforts.

Biopharma layoffs aren't letting up

Biopharma layoffs have held steady through mid-2025, and in this episode of "The Top Line," we dig into the numbers, closures and policy changes shaping the trend.

Non-opioid pain drug maker Pacira lays off 71 in California, retires facility in manufacturing upgrade

After years spent upgrading its manufacturing capabilities, Pacira BioSciences figures it’s time to retire a facility that has been running for more than a decade. Along with it, 8% of the company’s workforce is also headed for the exit.

State AGs unveil opioid settlements totaling $720M with 8 drugmakers

Viatris, Hikma, Amneal, Apotex, Indivior, Sun Pharma, Alvogen and Zydus will together pay states and governments up to $720 million, according to press releases from state attorneys general.

UnitedHealth names new CEOs for government programs, Medicaid

UnitedHealth Group has announced further leadership appointments as returning CEO Stephen Hemsley solidifies his executive team.

Fierce Pharma Asia—Approvals for Innovent, Dizal; BMS partner's bispecific ADC readout

China approved a first-in-class weight loss drug that Innovent Biologics licensed from Eli Lilly, Dizal won an FDA approval for a challenger to J&J's Rybrevant, while Biokin said a China phase 3 trial of its BMS-partnered bispecific ADC has met a primary endpoint. And more.
 
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Biopharma layoffs aren't letting up

Biopharma layoffs have held steady through mid-2025, and in this episode of "The Top Line," we dig into the numbers, closures and policy changes shaping the trend.
 

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