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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

11/09/2026 10:37 #Roche #Exelixis #FDA #Macro #U.S. stocks
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

10/09/2026 12:06 #Pharmaceutical Stocks #Biohaven #FDA #Macro #U.S. stocks
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

09/09/2026 13:14 #OTTAVA Surgical Robot #Johnson & Johnson #FDA #U.S. stocks
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

06/09/2026 17:22 #Nuvation Bio #FDA #Biotechnology #Macro #U.S. stocks
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

05/09/2026 11:46 #Gilead Sciences #FDA #Macro #U.S. stocks
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.

02/09/2026 13:51 #Exelixis #FDA #U.S. stocks
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

02/09/2026 12:18 #Drug Addiction #Fentanyl #FDA #the U.S. government #Macro
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

28/08/2026 07:15 #Drugs for Rare Diseases #Orladeyo #BioCryst #FDA #U.S. stocks
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

26/08/2026 16:01 #Pancreatic Cancer #Rasonque #FDA #U.S. stocks
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

26/08/2026 12:03 #Drug Research and Development #FDA #Moderna #U.S. stocks
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

26/08/2026 06:47 #BeiGene #Revolution Medicines #FDA #U.S. stocks #Hong Kong stocks
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

25/08/2026 13:07 #Medications #HHS #FDA #Artificial Intelligence #Macro #U.S. stocks
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

25/08/2026 12:14 #Gene Therapy #Genglycos #Ultragenyx #FDA #U.S. stocks
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.

07/08/2026 12:55 #Skin Cancer Medications #Replimune #FDA #U.S. stocks
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

03/08/2026 11:18 #Tissue Regeneration Technology #GLP-1 #Conexeu Sciences #FDA #Macro #U.S. stocks
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

28/07/2026 12:42 #Vaccine #FDA #Moderna #Financial Report
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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

11/09/2026 10:37 #Roche #Exelixis #FDA #Macro #U.S. stocks
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

10/09/2026 12:06 #Pharmaceutical Stocks #Biohaven #FDA #Macro #U.S. stocks
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

09/09/2026 13:14 #OTTAVA Surgical Robot #Johnson & Johnson #FDA #U.S. stocks
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

06/09/2026 17:22 #Nuvation Bio #FDA #Biotechnology #Macro #U.S. stocks
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

05/09/2026 11:46 #Gilead Sciences #FDA #Macro #U.S. stocks
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.

02/09/2026 13:51 #Exelixis #FDA #U.S. stocks
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

02/09/2026 12:18 #Drug Addiction #Fentanyl #FDA #the U.S. government #Macro
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

28/08/2026 07:15 #Drugs for Rare Diseases #Orladeyo #BioCryst #FDA #U.S. stocks
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

26/08/2026 16:01 #Pancreatic Cancer #Rasonque #FDA #U.S. stocks
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

26/08/2026 12:03 #Drug Research and Development #FDA #Moderna #U.S. stocks
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

26/08/2026 06:47 #BeiGene #Revolution Medicines #FDA #U.S. stocks #Hong Kong stocks
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

25/08/2026 13:07 #Medications #HHS #FDA #Artificial Intelligence #Macro #U.S. stocks
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

25/08/2026 12:14 #Gene Therapy #Genglycos #Ultragenyx #FDA #U.S. stocks
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.

07/08/2026 12:55 #Skin Cancer Medications #Replimune #FDA #U.S. stocks
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

03/08/2026 11:18 #Tissue Regeneration Technology #GLP-1 #Conexeu Sciences #FDA #Macro #U.S. stocks
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

28/07/2026 12:42 #Vaccine #FDA #Moderna #Financial Report
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