Fierce Pharma

NOVEMBER 16, 2023

Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Watch out, Pfizer and Roche. Watch out, Pfizer and Roche.

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Fierce Pharma

NOVEMBER 17, 2023

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi.

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Fierce Pharma

NOVEMBER 10, 2023

The FDA has approved the world’s first chikungunya vaccine, giving a thumbs-up to Valneva’s Ixchiq. The French company receives a priority review voucher from the FDA, which it said it will sell. Valneva has won the race in the U.S. | It is an accelerated approval and subject to a confirmatory, real-world study.

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Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week.

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Fierce Pharma

NOVEMBER 29, 2023

The revelation of an FDA investigation< | As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators.

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Fierce Pharma

JUNE 9, 2023

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.

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Fierce Pharma

NOVEMBER 8, 2023

Wednesday's FDA approval of Lilly's Zepbound to treat obesity closes the gap further. In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. | In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly.

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Fierce Pharma

SEPTEMBER 19, 2023

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality (..)

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Fierce Pharma

SEPTEMBER 13, 2023

But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work. For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. |

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Fierce Pharma

NOVEMBER 2, 2023

In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). | In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna.

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Fierce Pharma

SEPTEMBER 11, 2023

The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Out with the old and in with the new: Monday, the U.S. | Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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Fierce Pharma

OCTOBER 18, 2023

UCB has been “eagerly awaiting” an FDA approval for its psoriasis therapy Bimzelx (bimekizumab) after manufacturing problems resulted in a rejection last May. The FDA rejected the drug last May after conducting an inspection at UCB's Belgian manufacturing plant. Now, the wait is over. |

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Fierce Pharma

OCTOBER 16, 2023

Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery.

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Fierce Pharma

SEPTEMBER 28, 2023

Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions.

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Fierce Pharma

AUGUST 30, 2023

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.

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Fierce Pharma

OCTOBER 30, 2023

As an FDA decision draws closer on bluebird bio’s sickle cell disease gene therapy, the company has lined up a potential sale of a priority review voucher (PRV). | The company entered an advance agreement for a priority review voucher ahead of the FDA's decision on the sickle cell disease gene therapy prospect.

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Fierce Pharma

NOVEMBER 1, 2023

The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. | The FDA has approved Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara.

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Fierce Pharma

AUGUST 30, 2023

And the FDA's approval of several generics comes amid a U.S. After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff.

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Fierce Pharma

NOVEMBER 6, 2023

two high-ranking Republican lawmakers are pressing the FDA for answers. As shortages of drugs like amoxicillin, penicillin, Adderall and certain chemotherapies continue to confound doctors and patients in the U.S.,

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Fierce Pharma

SEPTEMBER 20, 2023

Positive FDA advisory committee votes aren’t always a blueprint for approval. Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.

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Fierce Pharma

NOVEMBER 20, 2023

Thanks to a new FDA approval, patients with ultra-rare desmoid tumors now have an FDA-approved treatment. Patients with ultra-rare desmoid tumors now have an FDA-approved treatment, thanks to a drug made by SpringWorks Therapeutics, which spun out of Pfizer in 2017 with a portfolio of rare disease candidates.

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Fierce Pharma

JUNE 29, 2023

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

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Fierce Pharma

OCTOBER 27, 2023

With the FDA approval of Agamree (vamorolone) to treat Duchenne | Thursday’s FDA approval of Santhera’s Agamree (vamorolone) to treat Duchenne muscular dystrophy (DMD) is just a start. The Swiss company is anxious to see how many disorders the first-in-class corticosteroid can treat.

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Fierce Pharma

OCTOBER 3, 2023

As Galderma attempts to round out its injectable aesthetics portfolio with approvals to resolve crow’s feet and frown lines, the FDA spotted a few manufacturing wrinkles in its RelabotulinumtoxinA | The agency spotted issues relating to chemistry, manufacturing and controls (CMC) processes in the company's application for its liquid botulinum (..)

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Fierce Pharma

OCTOBER 18, 2023

Within hours of each other, the Brussels-based company has scored FDA green lights for plaque psoriasis treatment Bimzelx and for generalized myasthenia gravis (gMG) drug Zilbrysq. Not only that, the Zilbrysq endorsement is UCB’s second in the indication this year, coming on top of the FDA signing off on UCB’s Rystiggo in June.

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Fierce Pharma

SEPTEMBER 26, 2023

It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver | The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent (..)

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Fierce Pharma

OCTOBER 12, 2023

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 C | A majority of Crohn's disease patients experienced a clinical response and clinical remission after treatment with mirikizumab, the company said.

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Fierce Pharma

OCTOBER 25, 2023

Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The FDA has already endorsed it for people 60 and older. The results could pave the way for the shot to be approved for this age group.

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Fierce Pharma

OCTOBER 9, 2023

Despite an endorsement from an advisory committee, the FDA has come to a different conclusion on the benefit-risk profile for Alnylam’s Onpattro in the rare heart disease transthyretin amyloidosis | Despite an endorsement from an advisory committee, the FDA has come to a different conclusion on the benefit-risk profile for Alnylam’s Onpattro in the (..)

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Fierce Pharma

OCTOBER 3, 2023

As an FDA advisory committee gears up to discuss the data supporting Amgen’s Lumakras, a pre-meeting briefing document from the agency suggests the KRAS inhibitor might have a tough road ahead. |

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Fierce Pharma

OCTOBER 17, 2023

After the FDA requested more data in 2021, Ardelyx instead defended its drug's profile through two appeals and an advisory committee meeting. The third time’s the charm for Ardelyx and its chronic kidney disease med Xphozah (tenapanor). Now, the company can celebrate a long-awaited win.

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Fierce Pharma

NOVEMBER 20, 2023

The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. . | It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. 16—will have to be pushed back pending an advisory committee meeting.

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Fierce Pharma

JUNE 7, 2023

As Alzheimer's disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval.

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Fierce Pharma

SEPTEMBER 20, 2023

UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. After a manufacturing-related complete response letter held up the U.S. | But now the company warned a decision will likely be delayed past the third quarter.

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Fierce Pharma

OCTOBER 20, 2023

FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. |

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Fierce Pharma

SEPTEMBER 25, 2023

The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous. | The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous. Now, the FDA found a fresh problem at a clinical trial site for Coherus’ Junshi Biosciences-partnered toripalimab.

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Fierce Pharma

OCTOBER 24, 2023

The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Qudrivalent. On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. |

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