FDA: Page 2

FDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug

Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.

By Jacob Bell • July 26, 2022

Novartis asks FDA to approve biosimilar for Biogen’s top-selling MS drug

Biogen will try to enforce patents protecting Tysabri, but an executive last week acknowledged that copycat drugs could launch when approved in the U.S.

By Jonathan Gardner • July 25, 2022

AstraZeneca, Daiichi breast cancer drug set for speedy FDA review

The agency agreed to quickly assess the companies’ drug Enhertu for “HER2 low” metastatic breast cancer, an indication for which it could become the first targeted treatment option.

By Ned Pagliarulo • July 25, 2022

Novartis, BeiGene cancer drug faces delay as FDA puts off approval decision

The deferral puts the drug in regulatory limbo, setting back the Swiss pharma's efforts to catch up to top immunotherapy developers Merck, Bristol Myers Squibb and Roche.

By Ned Pagliarulo • July 14, 2022

FDA clears Novavax's COVID-19 vaccine as 4th option in US

The shot is the first of its type authorized for COVID-19 by the FDA, but faces an uncertain future due to questions about its ability to fight omicron as well as the biotech’s ability to manufacture large quantities. 

By Jonathan Gardner • Updated July 13, 2022

FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug

The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

By Jonathan Gardner • July 6, 2022

In 'unusual' move, FDA to reconvene advisers for ALS drug review

The drug’s developer, Amylyx Pharmaceuticals, said the meeting is scheduled for Sept. 7 and experts will discuss additional data analyses conducted since the last time the panel met.

By Jacob Bell • July 5, 2022

Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow

A standard clearance could further broaden Paxlovid’s fast-rising use. But weaknesses are emerging too, among them unclear benefits in vaccinated people and a potential lack of potency against new variants.

By Delilah Alvarado • June 30, 2022

FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects

Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.

By Jonathan Gardner • June 30, 2022

5 FDA decisions to watch in the third quarter

Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as a cancer immunotherapy from Novartis. 

By Ben Fidler , Ned Pagliarulo , Jacob Bell , Jonathan Gardner • June 29, 2022

FDA suspends US testing of Sarepta Duchenne drug over safety concerns

The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.

By Ben Fidler • June 23, 2022

Bristol Myers CAR-T therapy cleared by FDA for earlier lymphoma use

Breyanzi is now approved in the second-line setting, matching Gilead’s Yescarta, which won a similar clearance from the FDA earlier this year.

By Ned Pagliarulo , Ben Fidler • June 23, 2022

FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children

The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use.

By Ned Pagliarulo • Updated June 19, 2022

FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

By Ben Fidler • Updated June 15, 2022

FDA approves Lilly, Incyte drug for alopecia, but includes safety warning

The partners’ JAK inhibitor Olumiant is the first systemic treatment for an autoimmune disease that causes hair loss. But known risks of heart attacks and cancer could complicate its launch. 

By Kristin Jensen • June 14, 2022

Alnylam wins FDA approval of rare disease drug in step toward profitability

Amvuttra, a transthyretin amyloidosis medicine previously known as vutrisiran, is viewed by biotech analysts as important to the company’s goal of ending years of financial losses.

By Ben Fidler • Updated June 14, 2022

FDA staff supportive of Pfizer, Moderna COVID vaccines in young children

Agency advisers will weigh data from the companies at a two-day meeting that begins Tuesday with discussion of Moderna’s shot in children and teens aged 6 to 17 years old. Use in kids under 5 will be debated Wednesday. 

By Jonathan Gardner , Ned Pagliarulo • June 13, 2022

FDA advisers offer unanimous support to second Bluebird gene therapy

By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs.

By Ned Pagliarulo • Updated June 10, 2022

FDA advisers back Novavax's latecomer COVID-19 vaccine

Outside experts debated the shot's safety profile and its efficacy versus the omicron variant but ultimately supported the vaccine, which is made using more traditional technology than Pfizer's and Moderna's.

By Jonathan Gardner • Updated June 7, 2022

FDA extends review of Amylyx ALS drug, delaying approval decision

The agency said it wanted more time to assess additional clinical trial data submitted by Amylyx, and set a new decision date of Sept. 29 for the closely watched treatment. 

By Ned Pagliarulo • June 3, 2022

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

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