FDA
FDA Cleared Regeneron's $0 Gene Therapy for Rare Hearing Loss
FDA cleared Regeneron's Otarmeni today, the first approved gene therapy for otoferlin-driven hearing loss.
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FDA
FDA Clears Regeneron Otarmeni, First Hearing Gene Therapy
FDA cleared Otarmeni, giving Regeneron the first-ever approval for a gene therapy to treat a rare type of inherited hearing loss.
Deals
AbbVie Builds $1.4B Durham Campus, First in North Carolina
AbbVie has allocated $1.4 billion for a manufacturing campus in Durham, North Carolina, its first in the state, drawn from the company's $100 billion US…
FDA
FDA Warns New Life Pharma After GLP-1 Inspection Refusal
FDA issued a warning letter to New Life Pharma on April 14 after the company's New Jersey facility blocked inspectors from two sections of its GLP-1…
Legal
Fined $30.5M in 2017, SQM Now Faces Resumed SEC FCPA Probe
The SEC issued SQM a subpoena in November 2023 under the Foreign Corrupt Practices Act, covering the Chilean miner's operations, compliance program, and…
Deals
Cut $1B Google Cloud Deal, Merck Targets HCP Engagement
Merck paid $1 billion to Google Cloud for access to its agentic AI platform, and the commercial team gets there first.
FDA
Ionis Filed Zilganersen for Sept. 22 FDA Decision; First AxD Drug
FDA accepted Ionis' filing for zilganersen for priority review last month, setting a September 22 deadline for what would be the first cleared treatment for…
Deals
Buys Kashiv for $1.1B, Amneal Eyes $200B Biosimilar Market
Amneal paid $1.1 billion to buy Kashiv BioSciences: $750 million upfront in cash and equity at close, plus up to $350 million tied to pipeline milestones.
Deals
Forager Bids $1B for Repay at 75% Premium
Forager Capital Management offered $1 billion for Atlanta-based Repay Holdings at $4.80 a share, a 75% premium to the stock's 30-day volume-weighted average…
Legal
Smartmatic Fights First Corporate FCPA Indictment Since 2010
The U.S. government charged Smartmatic in October 2025 with conspiracy to violate the FCPA's anti-bribery provisions, money laundering conspiracy, and money…
FDA
Pancreatic Cancer Hits Herceptin-Style 1998 Turning Point
Since Herceptin's approval in 1998, breast cancer has moved from a near-term death sentence to, in many cases, a chronic disease.
FDA
Cut 2 Abelacimab Cancer Trials, Novartis Bets $925M on Afib
Novartis is now betting its entire $925 million abelacimab investment on one remaining trial after the factor XI/XIa inhibitor failed to beat Eliquis in…
Deals
Paid $1.25B, Apollo Takes 13% of McKesson's Surgical Unit
Apollo Funds paid $1.25B for a 13% minority stake in McKesson's Medical/Surgical Solutions division, valuing MMS at roughly $13 billion.
FDA
Kyverna Sweeps All KYSA-8 Endpoints: 46% SPS Improvement, FDA Filing Next
Kyverna Therapeutics posted the full KYSA-8 dataset for miv-cel in stiff person syndrome at the American Academy of Neurology annual meeting, showing a 46%…
FDA
Gilead Cuts Arcus TIGIT Option After Domvanalimab's 2 Trial Failures
Gilead Sciences is walking away from most of its TIGIT collaboration with Arcus Biosciences after STAR-121, a Phase 3 study of domvanalimab in metastatic…
