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Protagonist Wins FDA Approval for MIMRYLO in Rare Blood Cancer Treatment
MarketBeat2d agobullish
Protagonist Wins FDA Approval for MIMRYLO in Rare Blood Cancer Treatment

Protagonist Therapeutics (NASDAQ:PTGX) said the U.S. Food and Drug Administration has approved rusfertide, to be marketed as MIMRYLO, for the treatment of erythrocytosis in adults with polycythemia vera, or PV. The approval marks the company’s second FDA-approved medicine this year, following the M

Guardant Health (GH) Surges on FDA Approval and Cancer Screening Momentum
Insider Monkey16d agobullish
Guardant Health (GH) Surges on FDA Approval and Cancer Screening Momentum

Aristotle Capital Management, LLC, an investment management company, released its “Core Equity Fund” Q2 2026 investor letter. A copy of the letter can be downloaded here. The fund returned 14.69% in the second quarter of 2026, slightly trailing the 15.20% gain of the S&P 500 Index as market performance remained highly concentrated in artificial intelligence (AI)-related […]

Bristol Myers Squibb (BMY) Wins FDA Approval, Is The Stock Fully Priced?
Simply Wall St.19d agobullish
Bristol Myers Squibb (BMY) Wins FDA Approval, Is The Stock Fully Priced?

Bristol Myers Squibb (BMY) is back in focus after the FDA granted accelerated approval for ZENBEXUS in a multiple myeloma combination regimen, introducing the first approved CELMoD therapy in this disease setting. See our latest analysis for Bristol-Myers Squibb. The ZENBEXUS approval lands at a time when Bristol-Myers Squibb’s momentum has picked up, with the share price at US$64.65 and a 30 day share price return of 13.52%. That builds on a 20.93% year to date share price return and a...

Coinbase beats much of customer lawsuit over US token sales
Reuters34d agobullish
Coinbase beats much of customer lawsuit over US token sales

NEW YORK, July 30 (Reuters) - Coinbase won the dismissal on Thursday of much of a lawsuit in which customers accused the largest U. ‌cryptocurrency exchange of illegally selling securities without registering as an exchange or ‌broker-dealer.

FDA Approves Johnson & Johnson Table-Integrated OTTAVA Robotic Surgery System
Benzinga40d agobullish
FDA Approves Johnson & Johnson Table-Integrated OTTAVA Robotic Surgery System

The U.S. Food and Drug Administration on Wednesday granted De Novo authorization for Johnson & Johnson’s OTTAVA Robotic Surgical System, marking the regulatory clearance of the world’s first table-integrated soft tissue robotic platform. The marketing clearance encompasses multiple general surgery...

Merck (MRK) Wins FDA Approval For First Oral PCSK9 Cholesterol Drug
Simply Wall St.45d agobullish
Merck (MRK) Wins FDA Approval For First Oral PCSK9 Cholesterol Drug

Merck (NYSE:MRK) received FDA approval for Lipfendra (enlicitide), the first oral PCSK9 cholesterol-lowering drug. Lipfendra introduces an oral option for patients who have so far relied on injectable PCSK9 therapies. The approval expands Merck’s presence in cardiovascular medicine as key products approach patent expirations. Merck, trading around $127.5, is adding Lipfendra to its portfolio at a time when NYSE:MRK has posted a 64.8% return over the past year and 92.2% over five years. The...

Eli Lilly (LLY) Wins Full FDA Approval For Retevmo In Broader Cancers
Simply Wall St.49d agobullish
Eli Lilly (LLY) Wins Full FDA Approval For Retevmo In Broader Cancers

FDA grants full approval to Eli Lilly's selpercatinib (Retevmo) for a wider group of adult and pediatric patients with RET fusion solid tumors. The decision shifts selpercatinib from accelerated to traditional approval and broadens its labeled use across multiple tumor types. The update reinforces Eli Lilly's (NYSE:LLY) position in oncology and opens new commercial and clinical avenues for the drug. Eli Lilly, known for its oncology and biopharma portfolio, now has a fully approved RET...

Pfizer (PFE) Wins FDA Approval For First Platinum Free Bladder Cancer Regimen
Simply Wall St.50d agobullish
Pfizer (PFE) Wins FDA Approval For First Platinum Free Bladder Cancer Regimen

Pfizer, trading as NYSE:PFE, received FDA approval for a platinum-free Padcev-Keytruda regimen in muscle-invasive bladder cancer. The regimen is approved as both neoadjuvant and adjuvant therapy for adult patients, regardless of cisplatin eligibility. This decision expands use of the combination across a broader bladder cancer population and introduces a new treatment option. For investors watching Pfizer at a share price of $24.25, this approval adds a fresh development to the oncology...

Pfizer (PFE) Wins FDA Approval For IBRANCE In HER2 Positive Breast Cancer
Simply Wall St.58d agobullish
Pfizer (PFE) Wins FDA Approval For IBRANCE In HER2 Positive Breast Cancer

Pfizer's IBRANCE has received new FDA approval as the first CDK4/6 inhibitor maintenance therapy for HR+, HER2+ metastatic breast cancer after induction treatment. The approval covers use of IBRANCE in combination with trastuzumab and endocrine therapy for patients with this subtype of breast cancer. The decision is based on results from the Phase 3 PATINA trial. For investors watching Pfizer (NYSE:PFE), this approval adds a fresh clinical milestone to a stock that has faced pressure in...

Vertex Pharmaceuticals (VRTX) Wins FDA Approval To Treat Two Year Olds With CASGEVY
Simply Wall St.61d agobullish
Vertex Pharmaceuticals (VRTX) Wins FDA Approval To Treat Two Year Olds With CASGEVY

FDA approved expanded use of CASGEVY for children as young as two years with sickle cell disease and transfusion-dependent beta thalassemia. The approval makes CASGEVY the first gene therapy of its kind available to this pediatric group in the U.S. Vertex Pharmaceuticals estimates that roughly 5,500 additional children in the U.S. may now be eligible for this one-time genetic treatment. Vertex Pharmaceuticals, traded as NasdaqGS:VRTX, now has FDA approval to offer CASGEVY to a much younger...

Klarna (KLAR) Wins Nearly $2 Billion As Google Loses Swedish Antitrust Case
Simply Wall St.63d agobullish
Klarna (KLAR) Wins Nearly $2 Billion As Google Loses Swedish Antitrust Case

Sweden's market court has ordered Google to pay nearly $2 billion in damages to Klarna Group's PriceRunner subsidiary. The court found that Google unlawfully favored its own shopping comparison service over rivals for several years. This ruling is described as one of the largest antitrust damages awards in Sweden and strengthens Klarna's position in comparison shopping. Klarna Group (NYSE:KLAR), which acquired PriceRunner in 2022, now has a substantial court-awarded claim tied directly to...

Gilead (GILD) Wins FDA Approval for Trodelvy in TNBC
Insider Monkey67d agobullish
Gilead (GILD) Wins FDA Approval for Trodelvy in TNBC

Gilead Sciences, Inc. (NASDAQ:GILD) is one of the 12 Most Profitable S&P 500 Stocks to Invest In. On June 25, 2026, the Food and Drug Administration approved Trodelvy from Gilead Sciences, Inc. (NASDAQ:GILD) for two indications in adults with triple-negative breast cancer. The first approval covers sacituzumab govitecan-hziy as a single agent for the first-line […]

AI stock surges amid multi-million-dollar lawsuit
TheStreet71d agobullish
AI stock surges amid multi-million-dollar lawsuit

Shares of Hut 8 (NASDAQ: HUT) tumbled in the pre-market session on June 22 but recovered lost ground after the morning bell. The stock fell about 7% to $112.50 after closing the prior day down 2.73% at $121.04. But at press time, the shares were trading 2.36% higher inraday and trading near ...

AbbVie’s (ABBV) Allergan Aesthetics Wins FDA Approval for Skinvive by Juvederm
Insider Monkey72d agobullish
AbbVie’s (ABBV) Allergan Aesthetics Wins FDA Approval for Skinvive by Juvederm

AbbVie Inc. (NYSE:ABBV) is one of the 12 High Quality Stocks to Buy for the Long Term. On June 16, 2026, Allergan Aesthetics, an AbbVie Inc. (NYSE:ABBV) company, announced the U.S. FDA approval of Skinvive by Juvederm to reduce neck lines and improve neck appearance in adults over the age of 21. AbbVie said Skinvive […]

Gilead (GILD) Wins FDA Approval for First HDV Treatment Hepcludex
Insider Monkey96d agobullish
Gilead (GILD) Wins FDA Approval for First HDV Treatment Hepcludex

Gilead Sciences, Inc. (NASDAQ:GILD) is one of the 12 Most Profitable Stocks to Invest In. On May 22, 2026, the U.S. Food and Drug Administration approved Hepcludex injection, granted to Gilead Sciences, Inc. (NASDAQ:GILD), to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. The FDA said bulevirtide is the […]