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The Trump administration announced the "America First Seafood Strategy" and launched Seafood.gov, while also providing over $5 billion in loans to expand the meat and seafood processing industries.
The Trump administration today unveiled the "American-First Seafood Strategy," aimed at securing the future of the U.S. seafood industry, and launched Seafood.gov, a website providing information on f
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Samsung Bioepis' first ADC candidate SBE303 wins FDA Fast Track designation for urothelial cancer treatment
Samsung Bioepis announced Wednesday that its first antibody-drug conjugate (ADC) candidate, SBE303, has been granted Fast Track designation by the US Food and Drug Administration (FDA). SBE303 targets
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FDA Panel Backs Grail's Galleri Cancer Test, But Medicare Payment Prospects Remain Uncertain
FDA Panel Backs Grail's Galleri Cancer Test, But Medicare Payment Prospects Remain Uncertain
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The U.S. FDA expert committee voted to support GRAIL's AI cancer early detection product, Galleri, deeming its clinical benefits to outweigh the risks.
At 9:23 AM ET, the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 10-0, 6-4, and 7-2 (with one abstention) to determine that Galleri has reasonable safety an
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Analysts: Rising US scrutiny on clinical trials could threaten China’s biotech advantage
Analysts warn that China's edge in fast, cost-effective early clinical trials, which has propelled its emergence as a global biopharmaceutical powerhouse, is at risk. US lawmakers and Food and Drug Ad
-
Teva agrees to be stalking-horse bidder for BioXcel's assets for up to $125 million, including $57.5 million upfront, with FDA and auction risks remaining
Teva Pharmaceutical Industries Limited (NYSE:TEVA) has agreed to serve as the initial bidder for substantially all of BioXcel Therapeutics, Inc. (NASDAQ:BTAI)'s assets in a court-supervised Section 36
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Exelixis (EXEL) stock dropped after FDA delayed potential approval of its new colon cancer treatment by three months
Exelixis (EXEL) stock dropped out of a buy zone Friday after the Food and Drug Administration delayed the potential approval of its new colon cancer treatment by three months. The combination includes
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Biohaven (BHVN) Stock Plummets After Pausing Midstage Seizure Treatment Study Due to Safety Concerns and FDA Toxicity Assessment Requirement
Biohaven (BHVN) stock plummeted Thursday after the company paused enrollment in a midstage study of its seizure treatment opakalim due to safety concerns. The Food and Drug Administration (FDA) is now
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Johnson & Johnson Plans Orthopedics Business Separation by Mid-2027, OTTAVA Surgical Robot Showing Positive Feedback
Johnson & Johnson (JNJ) MedTech Chairman Tim Schmid noted the planned separation of the company's orthopedics business, expected around mid-2027, with various separation structures being evaluated. He
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Jim Cramer calls surging biotech stock Nuvation Bio (NUVB) a "pure spec" despite analysts seeing 113% upside
Jim Cramer, during a September 3 episode of CNBC's Mad Money, labeled Nuvation Bio (NUVB) as "pure speculation," warning that its value primarily rests on potential future drug performance rather than
-
Gilead Sciences (GILD) received its third FDA approval in less than four months, with the latest being Bixlenvo approved on August 27 for the treatment of HIV-infected individuals.
Gilead Sciences has secured three U.S. Food and Drug Administration (FDA) approvals in less than four months. The most recent, on August 27, was for Bixlenvo as a daily oral medication for the treatme
-
Exelixis (EXEL), a cancer treatment company, saw its stock price hit a new all-time high on Wednesday, as the market focused on a key FDA action.
Exelixis (EXEL), a cancer treatment company, saw its stock price hit a new all-time high on Wednesday, as the market focused on a key FDA action.
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U.S. President highlights recovery efforts, noting 48.4 million Americans suffer from addiction
The President issued a message for National Recovery Month, celebrating over 23 million Americans who have found a path to recovery and renewing commitment to supporting those still struggling. The ad
-
BioCryst Pharmaceuticals Achieves Profitability, Eyes Acquisitions of Rare Disease Drugs
BioCryst CEO Charlie Gayer stated that the company achieved profitability last year and expects to be more profitable this year and next. Its rare disease drug Orladeyo, approved by the FDA in 2020, h
-
FDA approves Revolution Medicines' new pancreatic cancer drug daraxonrasib for market, the first targeted therapy, nearly doubling patients' median survival.
The U.S. Food and Drug Administration (FDA) has approved daraxonrasib (brand name Rasonque), a new pancreatic cancer drug from Revolution Medicines (RevMed), for market. This drug is the first targete
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Moderna's market value of $63.7 billion is not supported by its shrinking commercial revenue of $2.2 billion, with the company's valuation resting on its drug pipeline.
Moderna's commercial business has contracted, with trailing-twelve-month revenue falling to $2.2 billion from $3.1 billion a year earlier, and an operating margin of -150.2%. The company's valuation i
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BeiGene's net profit for the first half of the year surged by 385.8% year-on-year to US$464 million, with total revenue reaching US$3.219 billion.
BeiGene announced its results for the six months ended June 30, 2026, with total revenue increasing by 32.3% year-on-year. The global sales of its flagship product, BRUKINSA® (zanubrutinib), reached U
-
HHS Plans to Establish New FDA Deputy Commissioner Roles for Technology and Drugs
The U.S. Department of Health and Human Services (HHS) plans to create two new deputy commissioner roles at the Food and Drug Administration (FDA), according to sources. One position will focus on tec
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Ultragenyx (RARE) gene therapy Genglycos approved by FDA for treatment of Glycogen Storage Disease Type Ia, shares up 7.5% after hours.
The one-time gene therapy is the first approved therapy designed to address the underlying cause of Glycogen Storage Disease Type Ia (GSDIa), with a list price in the United States of approximately $2
-
Replimune wins FDA approval for its skin cancer drug, but shares tumble
Replimune has received FDA approval for its skin cancer drug, marking a successful third attempt to gain clearance. Despite the approval, the company's shares are tumbling.
-
Conexeu Sciences CEO Miles Harrison Highlights Tissue Regeneration Tech for GLP-1 Related Volume Loss, Eyes Early 2027 FDA Submission
During a fireside chat, Conexeu Sciences Inc. (Nasdaq: CNXU) CEO Miles Harrison discussed the company's preclinical-stage tissue regeneration technology, which aims to address large-volume tissue rest
-
Moderna Reports Second-Quarter Financial Results, with Revenue Exceeding Expectations and Profits for the Sixth Consecutive Quarter
Biotechnology company Moderna released its second-quarter 2026 financial results on July 31, reporting revenue of $389 million, exceeding the market’s consensus estimate of $236.36 million. This marks
-
The Trump administration announced the "America First Seafood Strategy" and launched Seafood.gov, while also providing over $5 billion in loans to expand the meat and seafood processing industries.
The Trump administration today unveiled the "American-First Seafood Strategy," aimed at securing the future of the U.S. seafood industry, and launched Seafood.gov, a website providing information on f
-
Samsung Bioepis' first ADC candidate SBE303 wins FDA Fast Track designation for urothelial cancer treatment
Samsung Bioepis announced Wednesday that its first antibody-drug conjugate (ADC) candidate, SBE303, has been granted Fast Track designation by the US Food and Drug Administration (FDA). SBE303 targets
-
FDA Panel Backs Grail's Galleri Cancer Test, But Medicare Payment Prospects Remain Uncertain
FDA Panel Backs Grail's Galleri Cancer Test, But Medicare Payment Prospects Remain Uncertain
-
The U.S. FDA expert committee voted to support GRAIL's AI cancer early detection product, Galleri, deeming its clinical benefits to outweigh the risks.
At 9:23 AM ET, the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 10-0, 6-4, and 7-2 (with one abstention) to determine that Galleri has reasonable safety an
-
Analysts: Rising US scrutiny on clinical trials could threaten China’s biotech advantage
Analysts warn that China's edge in fast, cost-effective early clinical trials, which has propelled its emergence as a global biopharmaceutical powerhouse, is at risk. US lawmakers and Food and Drug Ad
-
Teva agrees to be stalking-horse bidder for BioXcel's assets for up to $125 million, including $57.5 million upfront, with FDA and auction risks remaining
Teva Pharmaceutical Industries Limited (NYSE:TEVA) has agreed to serve as the initial bidder for substantially all of BioXcel Therapeutics, Inc. (NASDAQ:BTAI)'s assets in a court-supervised Section 36
-
Exelixis (EXEL) stock dropped after FDA delayed potential approval of its new colon cancer treatment by three months
Exelixis (EXEL) stock dropped out of a buy zone Friday after the Food and Drug Administration delayed the potential approval of its new colon cancer treatment by three months. The combination includes
-
Biohaven (BHVN) Stock Plummets After Pausing Midstage Seizure Treatment Study Due to Safety Concerns and FDA Toxicity Assessment Requirement
Biohaven (BHVN) stock plummeted Thursday after the company paused enrollment in a midstage study of its seizure treatment opakalim due to safety concerns. The Food and Drug Administration (FDA) is now
-
Johnson & Johnson Plans Orthopedics Business Separation by Mid-2027, OTTAVA Surgical Robot Showing Positive Feedback
Johnson & Johnson (JNJ) MedTech Chairman Tim Schmid noted the planned separation of the company's orthopedics business, expected around mid-2027, with various separation structures being evaluated. He
-
Jim Cramer calls surging biotech stock Nuvation Bio (NUVB) a "pure spec" despite analysts seeing 113% upside
Jim Cramer, during a September 3 episode of CNBC's Mad Money, labeled Nuvation Bio (NUVB) as "pure speculation," warning that its value primarily rests on potential future drug performance rather than
-
Gilead Sciences (GILD) received its third FDA approval in less than four months, with the latest being Bixlenvo approved on August 27 for the treatment of HIV-infected individuals.
Gilead Sciences has secured three U.S. Food and Drug Administration (FDA) approvals in less than four months. The most recent, on August 27, was for Bixlenvo as a daily oral medication for the treatme
-
Exelixis (EXEL), a cancer treatment company, saw its stock price hit a new all-time high on Wednesday, as the market focused on a key FDA action.
Exelixis (EXEL), a cancer treatment company, saw its stock price hit a new all-time high on Wednesday, as the market focused on a key FDA action.
-
U.S. President highlights recovery efforts, noting 48.4 million Americans suffer from addiction
The President issued a message for National Recovery Month, celebrating over 23 million Americans who have found a path to recovery and renewing commitment to supporting those still struggling. The ad
-
BioCryst Pharmaceuticals Achieves Profitability, Eyes Acquisitions of Rare Disease Drugs
BioCryst CEO Charlie Gayer stated that the company achieved profitability last year and expects to be more profitable this year and next. Its rare disease drug Orladeyo, approved by the FDA in 2020, h
-
FDA approves Revolution Medicines' new pancreatic cancer drug daraxonrasib for market, the first targeted therapy, nearly doubling patients' median survival.
The U.S. Food and Drug Administration (FDA) has approved daraxonrasib (brand name Rasonque), a new pancreatic cancer drug from Revolution Medicines (RevMed), for market. This drug is the first targete
-
Moderna's market value of $63.7 billion is not supported by its shrinking commercial revenue of $2.2 billion, with the company's valuation resting on its drug pipeline.
Moderna's commercial business has contracted, with trailing-twelve-month revenue falling to $2.2 billion from $3.1 billion a year earlier, and an operating margin of -150.2%. The company's valuation i
-
BeiGene's net profit for the first half of the year surged by 385.8% year-on-year to US$464 million, with total revenue reaching US$3.219 billion.
BeiGene announced its results for the six months ended June 30, 2026, with total revenue increasing by 32.3% year-on-year. The global sales of its flagship product, BRUKINSA® (zanubrutinib), reached U
-
HHS Plans to Establish New FDA Deputy Commissioner Roles for Technology and Drugs
The U.S. Department of Health and Human Services (HHS) plans to create two new deputy commissioner roles at the Food and Drug Administration (FDA), according to sources. One position will focus on tec
-
Ultragenyx (RARE) gene therapy Genglycos approved by FDA for treatment of Glycogen Storage Disease Type Ia, shares up 7.5% after hours.
The one-time gene therapy is the first approved therapy designed to address the underlying cause of Glycogen Storage Disease Type Ia (GSDIa), with a list price in the United States of approximately $2
-
Replimune wins FDA approval for its skin cancer drug, but shares tumble
Replimune has received FDA approval for its skin cancer drug, marking a successful third attempt to gain clearance. Despite the approval, the company's shares are tumbling.
-
Conexeu Sciences CEO Miles Harrison Highlights Tissue Regeneration Tech for GLP-1 Related Volume Loss, Eyes Early 2027 FDA Submission
During a fireside chat, Conexeu Sciences Inc. (Nasdaq: CNXU) CEO Miles Harrison discussed the company's preclinical-stage tissue regeneration technology, which aims to address large-volume tissue rest
-
Moderna Reports Second-Quarter Financial Results, with Revenue Exceeding Expectations and Profits for the Sixth Consecutive Quarter
Biotechnology company Moderna released its second-quarter 2026 financial results on July 31, reporting revenue of $389 million, exceeding the market’s consensus estimate of $236.36 million. This marks
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