FDA publishes 200 drug rejection letters

This Week

Jul 11, 2025

Biopharma layoffs for first half of the year jump 32% YOY


Trump renews 200% tariff threat on pharmaceuticals, indicates plan for grace period


FDA releases ‘initial batch’ of more than 200 drug rejection letters


FDA clears over-the-counter, cuffless blood pressure monitor with the Hilo bracelet


Merck boosts respiratory portfolio with $10B acquisition of Verona and potential COPD blockbuster Ohtuvayre


CSL trims R&D team, shifts focus toward external opportunities


New cadence at Jazz as Renee Gala replaces 16-year CEO Bruce Cozadd

 

Featured

Biopharma layoffs for first half of the year jump 32% YOY

Biopharma layoff rounds reported this May hit an all-time high, with 29 RIFs occurring—the most of any month reported over the last four years Fierce Biotech has spent tracking the measure.
 

Top Stories

Trump renews 200% tariff threat on pharmaceuticals, indicates plan for grace period

President Donald Trump has renewed his pledge of drug tariffs to the tune of 200%, but with a grace period of around one year.

FDA releases ‘initial batch’ of more than 200 drug rejection letters

The FDA has released an "initial batch" of more than 200 complete response letters (CRLs) in efforts to boost transparency.

FDA clears over-the-counter, cuffless blood pressure monitor with the Hilo bracelet

The FDA has cleared its first cuffless blood pressure monitor that will be available over-the-counter, with the Hilo wristband developed by Aktiia.

Merck boosts respiratory portfolio with $10B acquisition of Verona and potential COPD blockbuster Ohtuvayre

Merck has pulled off another acquisition which fits in its “sweet spot,” as described by CEO Rob Davis, paying $10 billion for Verona Pharma and its potential blockbuster Ohtuvayre, a first-in-class treatment for chronic obstructive pulmonary disorder (COPD).

CSL trims R&D team, shifts focus toward external opportunities

CSL is consolidating its R&D team in an effort to better position the organization “for long-term success in a rapidly evolving global environment.”

New cadence at Jazz as Renee Gala replaces 16-year CEO Bruce Cozadd

Renee Gala joins a short list of female biopharma chief executives as she is set to take the reins at Jazz Pharmaceuticals, replacing the company’s co-founder Bruce Cozadd, who in December announced his intention to step down, ending his 16-year run as CEO.

Novartis' malaria drug for babies wins world-first approval

Novartis and a Swiss nonprofit have made history, scoring the world’s first approval for a medicine to treat babies who are infected with malaria. The nod is for a new formulation of Coartem, which is also known commercially in come countries as Riamet.

Novo’s Wegovy retakes top TV spending spot in June, edging out AbbVie, J&J immunology ads

As summer began and temperatures rose in June, so too did TV ad spending for Novo Nordisk’s Wegovy.

AstraZeneca’s Alexion strengthens gene therapy offering with $825M AAV capsid pact

AstraZeneca’s rare disease unit Alexion has penned a $825 million deal for adeno-associated virus capsids from existing partner JCR Pharmaceuticals to develop genomic medicines.

Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility looms

After telegraphing plans to build a $2 billion end-to-end cell culture production facility in Holly Springs, North Carolina, in 2021, Fujifilm Biotechnologies will commence commercial operations under the first phase of the site’s buildout later this year.

Dizal to challenge J&J with FDA approval for lung cancer drug Zegfrovy

China's Dizal Pharmaceuticals has gained its first FDA approval, winning an accelerated nod for Zegfrovy to become the only U.S.-endorsed oral treatment for those with a rare type of non-small cell lung cancer.

After custom CRISPR success, new center launches with $20M to treat more kids with rare genetic diseases

KJ Muldoon recently made history by becoming the first patient to receive a personalized CRISPR gene therapy, designed specifically for the genetic mutations causing his rare metabolic disease. Now, a new $20 million effort from the Chan Zuckerberg Initiative and Innovative Genomics Institute endeavors to ensure KJ’s treatment isn’t a one-off.

KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly

The FDA has approved sebetralstat under the brand name Ekterly as a new, oral treatment option for acute attacks of hereditary angioedema (HAE) in adults and children ages 12 years and older. The nod came just a few short weeks after the agency missed its June 17 target date originally established for the decision.

‘We need bold action’: Amgen enlists NFL star to tackle dangers of LDL cholesterol in 1st documentary film

Amgen's “The Making of a Heart Attack” film premiered last month on A&E, was featured at the Cannes Lions International Festival of Creativity shortly after and is now available to watch on Amgen’s “Attack Heart Disease” website.

Novo keeps China manufacturing investments rolling with $112M for new quality testing lab in Tianjin

Novo Nordisk has inked a deal with the Tianjin Economic and Technological Development Area to invest roughly $112 million in an upgrade to the quality testing laboratory at its Tianjin, China, manufacturing facility, which has been in operation since 1994.
 
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Learn how clinical terminology helps life sciences teams streamline cohorting, reduce bias, and accelerate evidence generation.

 

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