FDA asks Lilly to evaluate obesity pill’s liver risk

The request, which is part of a just-released approval letter for Foundayo, comes amid an intensifying marketing battle between Lilly and Novo.

By Jonathan Gardner • April 15, 2026

J&J leans on Tremfya, cancer drugs to overcome Stelara losses

A growing multiple myeloma franchise helped the pharmaceutical giant top Wall Street’s expectations and surpass $15 billion in first-quarter drug sales.

By Jonathan Gardner • April 14, 2026

Explore the Trendline➔

Commercialization

New drugs for obesity are becoming blockbusters, while Trump administration pressure is reshaping pharma marketing strategies ahead of looming patent cliffs.

By BioPharma Dive staff

Lilly launches GLP-1 pill, kicking off showdown with Novo Nordisk

After winning the battle for injectable obesity medicines, Lilly hopes Foundayo can help it catch up in the oral market, where Novo has a three-month lead.

By Kristin Jensen • April 9, 2026

Hims & Hers says limited data stolen in social engineering attack

The telehealth provider said hackers gained access to a third-party customer service platform, but medical records remained secure.

By David Jones • April 6, 2026

FDA approves Lilly obesity pill, triggering battle with Novo Nordisk

Foundayo could erase the Wegovy pill’s four-month head start as the two drugmakers clash on a debate of efficacy and convenience.

By Jonathan Gardner • April 1, 2026

New FDA guidance could elevate pharma’s biosimilar market

Biologic copycats have had a limited impact on U.S. drug prices so far, but loosening regulatory restrictions could help accelerate their progress. 

By Michael Gibney • March 13, 2026

Lilly warns GLP-1 knockoffs may be ‘dangerous,’ escalating war with compounders

Lilly asked the FDA to step in after claiming that testing it’s done suggests copycat versions of Zepbound may carry “unknown risks.”

By Jonathan Gardner • March 12, 2026

FDA clears repurposed GSK drug for ultra-rare brain disease instead of autism

Months after promising help for “hundreds of thousands of kids,” the FDA approved the decades-old medicine for a disease documented in less than 50 people.

By Kristin Jensen • March 11, 2026

Novo, Hims reach deal to sell GLP-1 drugs together

The agreement ends a messy dispute that began when the telehealth firm attempted to sell a compounded form of Novo’s Wegovy pill at a cheaper price. 

By Ben Fidler • March 9, 2026

FDA issues speedy approval to J&J’s Tecvayli-Darzalex combo

The regimen’s clearance in early multiple myeloma was the third approval under the agency’s controversial “national priority” voucher program and issued only 55 days after the review began.

By Jonathan Gardner • March 6, 2026

Lilly targets employers in new bid to broaden access to obesity drugs

A service tailored to people with workplace-based insurance coverage represents a new way for Lilly to bypass insurers and expand use of its popular obesity shot. 

By Jonathan Gardner • March 5, 2026

Lilly’s GLP-1 pill tops Novo’s Rybelsus in head-to-head trial

Orforglipron, which could be approved for obesity next quarter, proved superior at cutting blood sugar and body weight — but at the expense of higher side effect rates. 

By Jonathan Gardner • Feb. 26, 2026

15 states sue HHS over changes to childhood vaccine schedule

The lawsuit seeks to reverse the abrupt overhaul of the U.S. immunization schedule as well as the federal government’s allegedly “unlawful” reformation of a key vaccine panel.

By Delilah Alvarado • Feb. 25, 2026

Vertex’s CRISPR therapy rebounds in latest earnings

Sales of Casgevy, a gene-edited treatment developed with CRISPR Therapeutics, more than tripled compared to the third quarter, a performance analysts saw as a bright spot in Vertex's report.

By Gwendolyn Wu • Feb. 13, 2026

Gilead dips as ‘strong’ earnings outweighed by high expectations for new HIV drug

Shares fell as much as 6% in after-hours trading, a decline one analyst guessed may be because Yeztugo’s trajectory isn’t matching investors’ sky-high hopes.

By Jacob Bell • Feb. 10, 2026

Earnings roundup: AbbVie angst, a bifurcated vaccine market and Bristol Myers’ waiting game

Vaccine makers are seeing sales declines in the U.S. and upswings in Europe. Elsewhere, investors fretted over an AbbVie franchise and Bristol Myers pointed to a trio of narrative-changing trials.

By BioPharma Dive staff • Feb. 5, 2026

Novo, Lilly sputter as Hims launches knockoff GLP-1 pill

Novo is threatening litigation in response, while FDA head Martin Makary, without naming specific companies, said the agency would take “swift action” against those “mass-marketing illegal copycat drugs.”  

By Ben Fidler • Updated Feb. 6, 2026

Express Scripts reaches ‘landmark’ settlement with FTC in insulin suit

The agreement announced Wednesday includes sweeping changes to the Cigna PBM’s business practices, including no longer preferring expensive drugs over cheaper equivalents on standard formularies and reshoring its controversial rebate aggregator.

By Rebecca Pifer Parduhn • Updated Feb. 4, 2026

Trump signs funding bill with PBM reforms, hospital-at-home and telehealth extensions

The funding package ends a partial government shutdown and enacts several healthcare policies, including preserving telehealth flexibilities in Medicare through 2027.

By Emily Olsen • Feb. 4, 2026

Novo shares tumble by double digits on grim sales outlook

In contrast to Lilly’s optimistic forecasts, Novo cited pricing constraints and competitive pressure in predicting up to a 13% decline in 2026 profits. 

By Jonathan Gardner • Feb. 4, 2026

Lilly soars again as fast-selling weight loss drugs top Wall Street projections

Despite some angst over pricing pressure for GLP-1 drugs, Lilly’s bullish projections surpassed consensus estimates, while combined 2025 sales of Zepbound and Mounjaro eclipsed $36 billion.

By Kristin Jensen • Feb. 4, 2026

Earnings roundup: Amgen vs. FDA, Pfizer’s defense and Merck’s $70B-in-sales plan

Amgen is refusing U.S. regulators’ request to withdraw an inflammatory disease drug. Elsewhere, Pfizer battled skepticism on new obesity drug data, and Merck laid out its post-Keytruda future.

By BioPharma Dive staff • Feb. 4, 2026

Drugs for cancer, arthritis and HIV on Medicare’s list for 2028 price cuts

Still, the medications in the latest round of negotiations — which now includes “Part B” drugs given in doctors offices — draw very limited revenue from Medicare, an analyst pointed out.

By Jonathan Gardner • Jan. 28, 2026

Lilly, chasing Novo, expects second-quarter FDA decision on obesity pill

Speaking at the J.P. Morgan conference, CEO David Ricks said he anticipates a “rapid review” for orforglipron that's currently speeding along “at pace.” 

By Jonathan Gardner • Jan. 14, 2026

Building more sustainable cold chain packaging through innovation

Working towards the future of cold chain packaging: sustainable packaging without performance tradeoffs.

By Cryopak • Jan. 12, 2026