FiercePharma

The biopharmaceutical industry is rapidly evolving, bringing fresh concepts to light every day. Subscribers turn to FiercePharma as their essential resource for the most current news, insights, and data regarding medications and the companies behind them. Each business day, FiercePharma and its associated publications provide comprehensive coverage of the pharmaceutical sector, spanning from late-stage drug development to all stages of the product lifecycle. Stay informed about topics such as regulatory approvals, negotiations with payers, manufacturing processes, marketing strategies, patent disputes, government inquiries and regulations, mergers and acquisitions, and much more.

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Bluebird bio warns of potential bankruptcy after another buyout delay

1 day ago | fiercepharma.com | Angus Liu

Bluebird bio shareholders have dragged their feet in tendering shares as part of the company’s sale process, prompting buyers Carlyle and SK Capital to extend their offer deadline once again. Bluebird investors now have until the end of day May 28, U.S. Eastern Daylight Time, to tender their shares, the acquirer group said, according to a bluebird securities filing Tuesday. The offer was previously scheduled to expire on Monday, May 12.
Pfizer partner RemeGen says HER2 ADC prolongs life in newly diagnosed bladder cancer

2 days ago | fiercepharma.com | Angus Liu

The HER2-targeted antibody-drug conjugate that Pfizer gained from its Seagen buyout has delivered positive results in a pivotal study among Chinese patients with newly diagnosed bladder cancer, a readout that bodes well for the New York pharma’s own global phase 3 trial.
AbbVie remains king in doctors’ perception of immunology drugmakers, but J&J regains some ground

2 days ago | fiercepharma.com | Andrea Park

Once again, AbbVie dominates doctors’ ranking of makers of immunology meds. Just like last year, the Skyrizi and Rinvoq maker scored the highest by far in ZoomRx’s analysis of how healthcare providers (HCPs) view immunology drugmakers. More than 50 doctors were asked to rate 15 pharmas in a variety of measures across five core factors—reputation, HCP-centricity, innovation, patient-centricity and promotion—all of which contribute to an overall perception score.
Abeona nets $155M with FDA voucher sale

2 days ago | fiercepharma.com | Eric Sagonowsky

Spring has been bountiful at Cleveland's Abeona Therapeutics. Two weeks after the company picked up FDA approval for its first commercial product, Abeona has inked a deal to sell the FDA Priority Review Voucher (PRV) it gained along with the approval. Abeona agreed to sell the PRV for $155 million, the company said in a Monday press release. The company didn't disclose the name of the buyer. PRVs can be used to speed up the review process for drug applications at the FDA.
AstraZeneca opens the door to Imfinzi expansion with trial win in high-risk bladder cancer patients

5 days ago | fiercepharma.com | Zoey Becker

AstraZeneca aims to widen the pool of bladder cancer patients who can be treated with its PD-L1 inhibitor Imfinzi after the drug demonstrated benefits in those with a higher-risk form of non-muscle-invasive bladder cancer (NMIBC).
Roche pledges nearly $300M to establish new Vabysmo production plant in China

5 days ago | fiercepharma.com | Fraiser Kansteiner

Even as Roche makes a major investment pledge across its U.S. business, the Swiss pharmaceutical giant isn’t neglecting its chief markets in Asia. Roche is investing roughly 2.04 billion Chinese yuan ($282 million) to erect a new biomanufacturing hub in Shanghai, China. The plant, which will mark Roche’s second for branded medicines in the country, will mainly be used for domestic production of the eye med Vabysmo, which goes by the commercial moniker Luoshijia in China.
Angela Hwang on her pivot from Big Pharma to biotech

5 days ago | fiercepharma.com | Ayla Ellison |Angus Liu

Angela Hwang spent nearly three decades at Pfizer before joining Flagship Pioneering in 2025 as a CEO-partner and the CEO of Metaphore Biotechnologies. In this week’s episode of "The Top Line," the former Pfizer chief commercial officer speaks with Fierce Pharma Deputy Editor Angus Liu about her transition from marketing drugs at a Big Pharma company to advancing novel technology at a young biotech startup.
Fierce Pharma Asia—Enhertu's neoadjuvant win; Takeda eyes inflection point; Trump targets foreign plants

6 days ago | fiercepharma.com | Angus Liu

Enhertu delivered a phase 3 trial win in early-stage breast cancer. Takeda spotlighted three late-stage readouts as a potential "inflection point" for the company. President Donald Trump is directing the FDA to go hard on foreign manufacturing facilities. And more. 1. AstraZeneca, Daiichi Sankyo's Enhertu rings up success in another breast cancer trialAstraZeneca and Daiichi Sankyo reported a positive readout for Enhertu as a neoadjuvant therapy in early-stage breast cancer.
Argenx brews up DTC push for Vyvgart Hytrulo prefilled syringe in generalized myasthenia gravis

6 days ago | fiercepharma.com | Andrea Park

Fresh off earning FDA approval for a prefilled syringe version of Vyvgart Hytrulo for at-home administration, argenx is building buzz with a new direct-to-consumer campaign. The “Treatment MY Way” push, which began Wednesday, centers on a minute-long commercial that’s set to roll out on broadcast TV. The ad follows three individuals, each of whom is decked out in Vyvgart Hytrulo’s now-signature purple shade and takes a visit to the My Way Corner Café.
FDA misses another approval decision target date, this time for GSK's Nucala in COPD

6 days ago | fiercepharma.com | Fraiser Kansteiner

In the wake of mass restructuring efforts across the Department of Health and Human Services, the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod for its IL-5 antibody Nucala in chronic obstructive pulmonary disease (COPD) on Wednesday, but the May 7 deadline has come and gone without a decision from the U.S. regulator. “Based on our latest discussions with the FDA, we continue to expect approval,” a GSK spokesperson said in an email.