FDA

Pfizer says 3 doses of its COVID-19 vaccine works in youngest children

The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.

By Jonathan Gardner • May 23, 2022

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

By Jacob Bell • May 17, 2022

Explore the Trendline➔

The BioPharma Dive Outlook on 2022

After surging into 2021, biotech crashed at the end of last year amid negative clinical trial readouts, ebbing M&A and broader investor pullback. But the year ahead figures to be busy on several fronts and a slate of important studies could deliver good news. 

By BioPharma Dive staff

Lilly wins FDA approval for new kind of diabetes drug

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

By Jonathan Gardner • Updated May 16, 2022

BridgeBio sale of FDA voucher good news for Bluebird, other biotech sellers

The drugmaker was able to get $110 million for its voucher, a kind of regulatory fast pass. Other vouchers have sold for similar amounts, boding well for Bluebird, which plans to sell two that it hopes to get this year.

By Ned Pagliarulo • May 13, 2022

With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

The proposed changes could have a notable impact on cell and gene therapy developers, many of which are advancing rare disease therapies that rely on speedy approval pathways.

By Jonathan Gardner • May 10, 2022

Traditional and bespoke registries

In order to truly understand the lived experience of a patient with a given condition or disease, several types of real-world data sources should be analyzed. 

May 9, 2022

FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect

The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.

By Ben Fidler • May 6, 2022

AstraZeneca and Daiichi set to broaden use of breast cancer drug, challenging Roche

The FDA cleared Enhertu for second-line use in HER2-positive disease, the latest inroads the partners have made against Roche’s dominant portfolio of breast cancer medicines.

By Ben Fidler • May 5, 2022

Spero to lay off 75% of workforce, change strategy after FDA challenges study results

Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring.

By Ben Fidler • May 4, 2022

FDA rejects two China-developed cancer drugs

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

By Jonathan Gardner • May 2, 2022

Understanding real-world data in the real world

Real-world data (RWD) and real-world evidence (RWE) are valuable across the entire pharmaceutical product lifecycle, from examining patient outcomes to supporting disease education and awareness and beyond. 

May 2, 2022

Moderna seeks FDA clearance for COVID-19 vaccine in young children

The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination. 

By Kristin Jensen • April 28, 2022

FDA panel supports agency push to raise approval bar for certain cancer drugs

Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.

By Jonathan Gardner • April 22, 2022

GSK to test FDA's tough stance on anemia pills

Unlike treatments from Akebia and FibroGen, GSK's drug hasn't been tied to a higher risk of heart problems, potentially easing the agency's concerns.

By Ben Fidler • April 19, 2022

Troubling data leads a biotech to pull its prized drug from market and FDA review

Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

By Jacob Bell • April 18, 2022

Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds

A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.

By Kristin Jensen • April 14, 2022

FDA clears Gilead to restart some studies of top cancer drug

The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.

By Ben Fidler • April 12, 2022

'Where's the patient?': Experts question FDA's device recall guidance

While the guidance encouraged the use of electronic communications in recalls — a change experts have advocated for — some questioned why the agency did not address more problems with the system.

By Ricky Zipp • April 6, 2022

FDA advisers grapple with how to update COVID-19 vaccines

About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.

By Ned Pagliarulo • Updated April 7, 2022

FDA halts Vir, GSK antibody use in response to COVID subvariant's spread

The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however.

By Kristin Jensen • April 6, 2022

Novartis breast cancer drug approved for ultra-rare condition

The FDA's decision was based on real-world study data that indicated Novartis' Piqray could treat a cluster of conditions known collectively as PROS.

By Ned Pagliarulo • April 6, 2022

CAR-T treatment moves earlier as FDA widens approval of Gilead's Yescarta

Yescarta, previously cleared only for use in treating late-stage lymphoma, can now be used after initial treatment has failed, a first for the cellular drugs.

By Ned Pagliarulo • April 4, 2022

5 FDA decisions to watch in the second quarter

While a market downturn has weighed on the biotech industry, FDA approvals for drugs from Bristol Myers Squibb, Bluebird bio and Amylyx Pharmaceuticals could help the sector regain its footing.

By Ben Fidler , Ned Pagliarulo , Jacob Bell • March 31, 2022

FDA rejects Akebia drug, dealing another blow to anemia pills

The biotech's experimental medicine, meant to be a convenient alternative to widely used injectable drugs like Aranesp, is the second of its kind to be knocked back by the agency due to safety concerns.

By Jonathan Gardner • March 30, 2022

FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances

The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.

By Jacob Bell • Updated March 30, 2022